Trial Outcomes & Findings for Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis (NCT NCT01147666)
NCT ID: NCT01147666
Last Updated: 2022-01-11
Results Overview
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. Last observation carried forward (LOCF) method was used to impute missing values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
161 participants
Primary outcome timeframe
Week 7
Results posted on
2022-01-11
Participant Flow
Normoresponder participants were enrolled sequentially in 10 cohorts (A-1 to A-10) with the exception of Cohort A-5 in parallel enrollment with A-6 to A-8. Hyporesponder participants were enrolled in 2 cohorts (B-1 and B-2). Normoresponder participants were those with stable baseline epoetin alfa doses between 75 and 450 international units (IU)/kilogram (kg)/week, while hyporeponders required maintenance epoetin alfa dose above 450 IU/kg/week.
Participant milestones
| Measure |
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 milligrams (mg)/kg, administered orally 3 times weekly (TIW) in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target hemoglobin (Hb) values (11.0-13.0 grams \[g\]/deciliter \[dL\]) was based upon regular monitoring of Hb.
|
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
Normoresponsive participants received intravenous (IV) epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dosing Period 1: 6-Week Treatment
STARTED
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
2
|
10
|
36
|
4
|
5
|
4
|
4
|
|
Dosing Period 1: 6-Week Treatment
Received at Least 1 Dose of Study Drug
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
2
|
10
|
36
|
4
|
5
|
4
|
4
|
|
Dosing Period 1: 6-Week Treatment
Efficacy Evaluable (EE) Population
|
10
|
9
|
9
|
11
|
11
|
11
|
11
|
10
|
2
|
10
|
31
|
1
|
3
|
4
|
3
|
|
Dosing Period 1: 6-Week Treatment
COMPLETED
|
10
|
11
|
10
|
10
|
7
|
9
|
9
|
9
|
2
|
8
|
33
|
2
|
1
|
3
|
0
|
|
Dosing Period 1: 6-Week Treatment
NOT COMPLETED
|
2
|
1
|
2
|
2
|
5
|
3
|
3
|
3
|
0
|
2
|
3
|
2
|
4
|
1
|
4
|
|
Dosing Period 2: 19-Week Treatment
STARTED
|
0
|
0
|
0
|
7
|
12
|
12
|
12
|
12
|
2
|
10
|
23
|
0
|
5
|
3
|
3
|
|
Dosing Period 2: 19-Week Treatment
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
7
|
12
|
12
|
12
|
12
|
2
|
10
|
23
|
0
|
5
|
3
|
3
|
|
Dosing Period 2: 19-Week Treatment
EE Population for 19-week Treatment
|
0
|
0
|
0
|
6
|
11
|
11
|
11
|
10
|
2
|
10
|
22
|
0
|
3
|
3
|
2
|
|
Dosing Period 2: 19-Week Treatment
COMPLETED
|
0
|
0
|
0
|
5
|
7
|
9
|
9
|
9
|
2
|
8
|
21
|
0
|
1
|
2
|
0
|
|
Dosing Period 2: 19-Week Treatment
NOT COMPLETED
|
0
|
0
|
0
|
2
|
5
|
3
|
3
|
3
|
0
|
2
|
2
|
0
|
4
|
1
|
3
|
Reasons for withdrawal
| Measure |
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 milligrams (mg)/kg, administered orally 3 times weekly (TIW) in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target hemoglobin (Hb) values (11.0-13.0 grams \[g\]/deciliter \[dL\]) was based upon regular monitoring of Hb.
|
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
Normoresponsive participants received intravenous (IV) epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dosing Period 1: 6-Week Treatment
Death
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dosing Period 1: 6-Week Treatment
Adverse Event
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dosing Period 1: 6-Week Treatment
Lack of Efficacy
|
1
|
0
|
0
|
0
|
3
|
1
|
2
|
2
|
0
|
1
|
0
|
0
|
1
|
0
|
3
|
|
Dosing Period 2: 19-Week Treatment
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dosing Period 1: 6-Week Treatment
Protocol Violation
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Dosing Period 1: 6-Week Treatment
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
|
Dosing Period 1: 6-Week Treatment
Other than specified
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Dosing Period 1: 6-Week Treatment
Non-compliance with study drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Dosing Period 2: 19-Week Treatment
Death
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dosing Period 2: 19-Week Treatment
Lack of Efficacy
|
0
|
0
|
0
|
0
|
3
|
1
|
2
|
2
|
0
|
1
|
0
|
0
|
1
|
0
|
2
|
|
Dosing Period 2: 19-Week Treatment
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Dosing Period 2: 19-Week Treatment
Other than specified
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Dosing Period 2: 19-Week Treatment
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dosing Period 2: 19-Week Treatment
Non-compliance with study drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis
Baseline characteristics by cohort
| Measure |
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=2 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=36 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
n=4 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=5 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=4 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=4 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 19.4 • n=4 Participants
|
55.2 years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
58.7 years
STANDARD_DEVIATION 10.1 • n=8 Participants
|
61.9 years
STANDARD_DEVIATION 11.9 • n=8 Participants
|
55.7 years
STANDARD_DEVIATION 14.5 • n=24 Participants
|
57.0 years
STANDARD_DEVIATION 17.0 • n=42 Participants
|
55.8 years
STANDARD_DEVIATION 6.8 • n=42 Participants
|
57.9 years
STANDARD_DEVIATION 11.0 • n=42 Participants
|
55.0 years
STANDARD_DEVIATION 8.8 • n=42 Participants
|
60.2 years
STANDARD_DEVIATION 5.9 • n=36 Participants
|
47.0 years
STANDARD_DEVIATION 12.5 • n=36 Participants
|
58.8 years
STANDARD_DEVIATION 8.6 • n=24 Participants
|
56.3 years
STANDARD_DEVIATION 3.680644 • n=135 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
61 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
100 Participants
n=135 Participants
|
PRIMARY outcome
Timeframe: Week 7Population: EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (erythropoiesis-stimulating agent \[ESA\], IV Iron or red blood cell \[RBC\] transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy. Here, 'Overall number of participants analyzed' signifies normoresponder participants who were treated for 6 weeks only.
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. Last observation carried forward (LOCF) method was used to impute missing values.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=9 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=9 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=5 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=9 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only
|
4 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 7Population: EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy.
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=1 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=3 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=4 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=3 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Weeks 17, 18, 19, and 20Population: EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.
The average of the mean Hb values that were above 11 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=6 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=10 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=2 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=22 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=3 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=3 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=2 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks
|
4 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 17, 18, 19, and 20Population: EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.
The average of the mean Hb values that were within 11-13 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=6 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=10 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=2 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=22 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=3 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=3 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=2 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Mean of Hb Within 11-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)
|
4 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 17, 18, 19, and 20Population: EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.
The average of the mean Hb values that were within 10-13 g/dL at Weeks 17, 18, 19, and 20 are presented. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. LOCF method was used to impute missing values.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=6 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=10 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=2 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=22 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Mean of Hb Within 10-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)
|
5 Participants
|
2 Participants
|
10 Participants
|
10 Participants
|
7 Participants
|
2 Participants
|
6 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 7Population: EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy.
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=9 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=9 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=11 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=10 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=2 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=10 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=31 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
n=1 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=3 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=4 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=3 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hb at Week 7 for Participants Treated for at Least 6 Weeks
|
-0.40 g/dL
Standard Deviation 1.56
|
0.91 g/dL
Standard Deviation 1.59
|
0.71 g/dL
Standard Deviation 1.61
|
0.25 g/dL
Standard Deviation 1.86
|
-0.15 g/dL
Standard Deviation 1.36
|
-0.18 g/dL
Standard Deviation 1.55
|
-0.32 g/dL
Standard Deviation 1.39
|
-0.47 g/dL
Standard Deviation 0.94
|
-0.00 g/dL
Standard Deviation 2.12
|
0.24 g/dL
Standard Deviation 1.82
|
-0.51 g/dL
Standard Deviation 1.31
|
-2.63 g/dL
|
-0.89 g/dL
Standard Deviation 0.74
|
-0.28 g/dL
Standard Deviation 0.81
|
-2.50 g/dL
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 10, 12, 14, 17, 19, and 20Population: EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=6 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=10 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=2 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=22 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=3 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=3 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=2 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks
Change at Week 20
|
-0.39 g/dL
Standard Deviation 1.16
|
-0.55 g/dL
Standard Deviation 1.88
|
-0.55 g/dL
Standard Deviation 1.24
|
-0.82 g/dL
Standard Deviation 1.27
|
-0.33 g/dL
Standard Deviation 1.34
|
0.15 g/dL
Standard Deviation 0.07
|
-0.57 g/dL
Standard Deviation 1.68
|
-0.36 g/dL
Standard Deviation 1.50
|
-2.82 g/dL
Standard Deviation 1.19
|
0.12 g/dL
Standard Deviation 2.14
|
-2.47 g/dL
Standard Deviation 0.14
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks
Change at Week 8
|
0.49 g/dL
Standard Deviation 1.31
|
0.08 g/dL
Standard Deviation 1.56
|
0.01 g/dL
Standard Deviation 1.51
|
-0.49 g/dL
Standard Deviation 1.49
|
-0.29 g/dL
Standard Deviation 1.09
|
0.05 g/dL
Standard Deviation 2.05
|
0.20 g/dL
Standard Deviation 1.85
|
-0.21 g/dL
Standard Deviation 1.02
|
-0.89 g/dL
Standard Deviation 0.99
|
-0.41 g/dL
Standard Deviation 1.52
|
-2.37 g/dL
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks
Change at Week 10
|
0.56 g/dL
Standard Deviation 1.49
|
0.17 g/dL
Standard Deviation 1.65
|
-0.17 g/dL
Standard Deviation 1.32
|
-0.56 g/dL
Standard Deviation 1.35
|
-0.27 g/dL
Standard Deviation 1.22
|
-0.15 g/dL
Standard Deviation 0.07
|
0.26 g/dL
Standard Deviation 2.07
|
-0.34 g/dL
Standard Deviation 1.19
|
-1.46 g/dL
Standard Deviation 1.41
|
0.19 g/dL
Standard Deviation 1.48
|
-2.37 g/dL
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks
Change at Week 12
|
0.26 g/dL
Standard Deviation 1.49
|
0.04 g/dL
Standard Deviation 1.57
|
-0.10 g/dL
Standard Deviation 1.42
|
-0.56 g/dL
Standard Deviation 1.44
|
-0.35 g/dL
Standard Deviation 1.17
|
-0.15 g/dL
Standard Deviation 0.92
|
0.38 g/dL
Standard Deviation 2.28
|
-0.48 g/dL
Standard Deviation 1.20
|
-2.02 g/dL
Standard Deviation 1.47
|
-0.08 g/dL
Standard Deviation 2.50
|
-2.37 g/dL
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks
Change at Week 14
|
0.53 g/dL
Standard Deviation 1.55
|
-0.03 g/dL
Standard Deviation 1.73
|
-0.27 g/dL
Standard Deviation 1.29
|
-0.41 g/dL
Standard Deviation 1.44
|
-0.24 g/dL
Standard Deviation 1.68
|
-0.15 g/dL
Standard Deviation 1.77
|
0.33 g/dL
Standard Deviation 2.37
|
-0.50 g/dL
Standard Deviation 1.23
|
-2.29 g/dL
Standard Deviation 1.71
|
0.42 g/dL
Standard Deviation 1.83
|
-2.37 g/dL
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks
Change at Week 17
|
-0.09 g/dL
Standard Deviation 0.88
|
-0.09 g/dL
Standard Deviation 1.96
|
-0.27 g/dL
Standard Deviation 1.07
|
-0.48 g/dL
Standard Deviation 1.42
|
-0.27 g/dL
Standard Deviation 1.18
|
-0.30 g/dL
Standard Deviation 0.85
|
0.02 g/dL
Standard Deviation 2.06
|
-0.45 g/dL
Standard Deviation 1.57
|
-2.69 g/dL
Standard Deviation 1.61
|
0.16 g/dL
Standard Deviation 2.27
|
-2.37 g/dL
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks
Change at Week 19
|
-0.11 g/dL
Standard Deviation 1.18
|
-0.32 g/dL
Standard Deviation 1.84
|
-0.28 g/dL
Standard Deviation 1.07
|
-0.82 g/dL
Standard Deviation 1.19
|
-0.35 g/dL
Standard Deviation 1.20
|
0.05 g/dL
Standard Deviation 0.07
|
-0.10 g/dL
Standard Deviation 2.03
|
-0.30 g/dL
Standard Deviation 1.43
|
-3.02 g/dL
Standard Deviation 1.08
|
0.12 g/dL
Standard Deviation 2.27
|
-2.37 g/dL
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 6Population: Safety population included all participants who were randomized and received at least one dose of study medication. Here, 'Overall number of participants analyzed' signifies participants who were treated for 6 weeks only.
Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=5 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=13 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only
Dose Increased
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only
Dose Reduced
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only
Dose Interrupted
|
4 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only
Dose Resume
|
0 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 19Population: Safety population included all participants who were randomized and received at least one dose of study medication.
Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=7 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=12 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=2 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=23 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks
Dose Resume
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks
Dose Increased
|
2 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks
Dose Reduced
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks
Dose Interrupted
|
1 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 7Population: EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=9 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=9 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=11 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=10 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=2 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=10 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=31 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
n=1 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=3 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=4 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=3 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for At Least 6 Weeks
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
19 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 7Population: EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=6 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=10 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=2 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=22 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=3 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=3 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=2 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for 19 Weeks
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
13 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 7Population: EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy. Here, 'Overall number of participants analyzed' signifies participants who were treated for 6 weeks only.
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=9 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=9 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=5 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=9 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Treated for 6 Weeks Only Whose Hb Levels at Week 7 Were Greater Than Their Baseline Level
|
3 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 8, 10, 12, 14, 17, 19, and 20Population: EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=6 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=11 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=10 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=2 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=22 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level
Week 8
|
3 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level
Week 10
|
3 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level
Week 12
|
3 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level
Week 14
|
3 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level
Week 17
|
2 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level
Week 19
|
2 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level
Week 20
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 6Population: Safety population included all participants who were randomized and received at least one dose of study medication.
Rescue anemia treatment included any ESA dosing, RBC transfusion, or IV iron.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=12 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=12 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=2 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=10 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=36 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
n=4 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=5 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=4 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=4 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for at Least 6 Weeks
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 19Population: Safety population included all participants who were randomized and received at least one dose of study medication.
Rescue anemia treatment included any ESA dosing, RBC transfusion, or IV iron.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=7 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=12 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=2 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=23 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=5 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=3 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=3 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for 19-Weeks
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 6Population: Safety population included all participants who were randomized and received at least one dose of study medication.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=12 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=12 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=2 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=10 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=36 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
n=4 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=5 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=4 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=4 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for at Least 6-Weeks
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 19Population: Safety population included all participants who were randomized and received at least one dose of study medication.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=7 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=12 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=12 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=2 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=23 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=5 Participants
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=3 Participants
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=3 Participants
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for 19-Weeks
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 6Population: EE included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy. Here, 'Overall number of participants analyzed' signifies participants who were treated for 6 weeks only.
The rate of rise was computed as the slope of the regression line of change in Hb level (in g/dL) vs. time (in weeks) using Random Coefficient Model. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Outcome measures
| Measure |
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=9 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=10 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=9 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=5 Participants
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A (Epoetin Alfa)
n=9 Participants
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Rate of Change in Hb Levels, Measured by Regression Slopes of the Hb Values During Treatment up to Week 6
|
-0.0135 g/dL/week
|
0.1926 g/dL/week
|
0.1682 g/dL/week
|
-0.0220 g/dL/week
|
-0.1267 g/dL/week
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 4, 8, 12, 24, 48, and 72 hours postdose at Weeks 1 and 6Population: Data for trough plasma concentration of roxadustat and epoetin alfa were not collected for this study.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort A-9 (Roxadustat 2.0 mg/kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohorts A (Epoetin Alfa)
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort B (Epoetin Alfa)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B (Placebo)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=2 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=10 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=36 participants at risk
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
n=4 participants at risk
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=5 participants at risk
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=4 participants at risk
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=4 participants at risk
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Gangrene
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
20.0%
1/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Infection
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
5.6%
2/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
10.0%
1/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
10.0%
1/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
20.0%
1/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
16.7%
2/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
10.0%
1/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
20.0%
1/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
10.0%
1/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
2.8%
1/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
Other adverse events
| Measure |
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)
n=12 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-9 (Roxadustat 2.0 mg/kg)
n=2 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)
n=10 participants at risk
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (\>60 to 90 kg), and heavy weight (\>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohorts A (Epoetin Alfa)
n=36 participants at risk
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
n=4 participants at risk
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
n=5 participants at risk
Hyporesponsive participants (with baseline epoetin alfa dosage \>115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
|
Cohort B (Epoetin Alfa)
n=4 participants at risk
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
|
Cohort B (Placebo)
n=4 participants at risk
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
16.7%
2/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
16.7%
2/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
16.7%
2/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
5.6%
2/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
20.0%
1/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
16.7%
2/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
10.0%
1/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
20.0%
1/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
General disorders
Fatigue
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
20.0%
1/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
20.0%
1/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
20.0%
1/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
20.0%
1/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
16.7%
2/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
8.3%
1/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
20.0%
2/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
General disorders
Catheter site pain
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
20.0%
1/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/12 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/2 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/10 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/36 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
25.0%
1/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/5 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
0.00%
0/4 • Baseline up to Week 23
Safety population included all participants who were randomized and received at least one dose of study medication.
|
Additional Information
Clinical Trial Information Desk
FibroGen, Inc.
Phone: 415-978-1441
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place