Trial Outcomes & Findings for Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia (NCT NCT01244763)
NCT ID: NCT01244763
Last Updated: 2022-02-10
Results Overview
An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
145 participants
Primary outcome timeframe
Up to Week 17
Results posted on
2022-02-10
Participant Flow
Participant milestones
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
Participants received roxadustat capsules, administered orally 3 times weekly (TIW) for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kilograms (kg)\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 milligrams \[mg\] roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to 2 times a week (BIW) at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to 1 time a week (QW) at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
24
|
24
|
25
|
|
Overall Study
Safety Population
|
24
|
24
|
24
|
24
|
24
|
25
|
|
Overall Study
Efficacy Evaluable (EE) Population
|
23
|
24
|
23
|
24
|
24
|
25
|
|
Overall Study
COMPLETED
|
21
|
21
|
22
|
23
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
1
|
3
|
4
|
Reasons for withdrawal
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
Participants received roxadustat capsules, administered orally 3 times weekly (TIW) for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kilograms (kg)\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 milligrams \[mg\] roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to 2 times a week (BIW) at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to 1 time a week (QW) at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
1
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Enrolled into the Extension Study
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
Baseline characteristics by cohort
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=24 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=24 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
61.8 years
STANDARD_DEVIATION 13.2 • n=21 Participants
|
65.2 years
STANDARD_DEVIATION 8.6 • n=8 Participants
|
64.4 years
STANDARD_DEVIATION 11.3 • n=8 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
92 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
53 Participants
n=8 Participants
|
|
Hb
|
9.56 g/dL
STANDARD_DEVIATION 0.86 • n=5 Participants
|
9.67 g/dL
STANDARD_DEVIATION 0.62 • n=7 Participants
|
9.80 g/dL
STANDARD_DEVIATION 0.49 • n=5 Participants
|
9.68 g/dL
STANDARD_DEVIATION 0.77 • n=4 Participants
|
9.89 g/dL
STANDARD_DEVIATION 0.60 • n=21 Participants
|
9.72 g/dL
STANDARD_DEVIATION 0.60 • n=8 Participants
|
9.72 g/dL
STANDARD_DEVIATION 0.66 • n=8 Participants
|
PRIMARY outcome
Timeframe: Up to Week 17Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study.
An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=23 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=23 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Number (%) of Participants With an Hb Response by Week 17
|
19 Participants
|
24 Participants
|
21 Participants
|
23 Participants
|
23 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=23 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=23 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25
Week 5
|
15 Participants
|
14 Participants
|
3 Participants
|
13 Participants
|
9 Participants
|
9 Participants
|
|
Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25
Week 9
|
18 Participants
|
21 Participants
|
12 Participants
|
20 Participants
|
18 Participants
|
13 Participants
|
|
Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25
Week 13
|
18 Participants
|
23 Participants
|
15 Participants
|
21 Participants
|
20 Participants
|
16 Participants
|
|
Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25
Week 17
|
19 Participants
|
24 Participants
|
17 Participants
|
22 Participants
|
23 Participants
|
20 Participants
|
|
Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25
Week 21
|
—
|
—
|
19 Participants
|
22 Participants
|
23 Participants
|
21 Participants
|
|
Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25
Week 25
|
—
|
—
|
21 Participants
|
23 Participants
|
23 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
Baseline is defined as the mean of the last 3 available values predose.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=23 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=23 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25
Baseline
|
9.56 g/dL
Standard Deviation 0.88
|
9.67 g/dL
Standard Deviation 0.62
|
9.80 g/dL
Standard Deviation 0.50
|
9.68 g/dL
Standard Deviation 0.77
|
9.89 g/dL
Standard Deviation 0.60
|
9.72 g/dL
Standard Deviation 0.60
|
|
Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25
Change at Week 5
|
1.71 g/dL
Standard Deviation 1.02
|
1.11 g/dL
Standard Deviation 0.96
|
0.57 g/dL
Standard Deviation 0.65
|
1.65 g/dL
Standard Deviation 0.95
|
0.74 g/dL
Standard Deviation 0.75
|
0.63 g/dL
Standard Deviation 0.85
|
|
Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25
Change at Week 9
|
2.58 g/dL
Standard Deviation 0.97
|
1.77 g/dL
Standard Deviation 1.18
|
0.99 g/dL
Standard Deviation 0.87
|
2.21 g/dL
Standard Deviation 1.02
|
1.67 g/dL
Standard Deviation 0.98
|
0.89 g/dL
Standard Deviation 1.23
|
|
Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25
Change at Week 13
|
2.46 g/dL
Standard Deviation 0.93
|
2.06 g/dL
Standard Deviation 1.07
|
1.26 g/dL
Standard Deviation 1.09
|
2.17 g/dL
Standard Deviation 1.19
|
1.43 g/dL
Standard Deviation 0.90
|
1.19 g/dL
Standard Deviation 1.10
|
|
Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25
Change at Week 17
|
2.63 g/dL
Standard Deviation 0.83
|
2.28 g/dL
Standard Deviation 0.87
|
1.43 g/dL
Standard Deviation 1.15
|
2.26 g/dL
Standard Deviation 1.31
|
1.50 g/dL
Standard Deviation 0.73
|
1.46 g/dL
Standard Deviation 1.23
|
|
Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25
Change at Week 21
|
—
|
—
|
1.30 g/dL
Standard Deviation 0.97
|
1.94 g/dL
Standard Deviation 0.81
|
1.19 g/dL
Standard Deviation 1.08
|
1.79 g/dL
Standard Deviation 0.77
|
|
Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25
Change at Week 25
|
—
|
—
|
1.33 g/dL
Standard Deviation 1.00
|
1.73 g/dL
Standard Deviation 1.14
|
1.28 g/dL
Standard Deviation 1.08
|
1.51 g/dL
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
Participants can have a Hb value reported for more than 1 of the categories (11-12, 11-13, and 10.5-13 g/dL) during the week intervals since these categories are not mutually exclusive.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=23 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=23 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-12, HB Value of 11-12 g/dL
|
5 Participants
|
12 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
6 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 5-8, HB Value of 11-12 g/dL
|
4 Participants
|
11 Participants
|
7 Participants
|
8 Participants
|
10 Participants
|
7 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 5-8, HB Value of 11-13 g/dL
|
13 Participants
|
14 Participants
|
7 Participants
|
12 Participants
|
13 Participants
|
8 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 5-8, HB Value of 10.5-13 g/dL
|
16 Participants
|
18 Participants
|
14 Participants
|
16 Participants
|
17 Participants
|
13 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-12, HB Value of 11-13 g/dL
|
13 Participants
|
18 Participants
|
9 Participants
|
16 Participants
|
12 Participants
|
10 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-12, HB Value of 10.5-13 g/dL
|
14 Participants
|
21 Participants
|
16 Participants
|
17 Participants
|
16 Participants
|
15 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-16, HB Value of 11-12 g/dL
|
6 Participants
|
11 Participants
|
8 Participants
|
8 Participants
|
11 Participants
|
7 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-16, HB Value of 11-13 g/dL
|
12 Participants
|
19 Participants
|
11 Participants
|
16 Participants
|
14 Participants
|
11 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-16, HB Value of 10.5-13 g/dL
|
14 Participants
|
22 Participants
|
15 Participants
|
19 Participants
|
20 Participants
|
17 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 13-16, HB Value of 11-12 g/dL
|
6 Participants
|
10 Participants
|
9 Participants
|
9 Participants
|
14 Participants
|
9 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 13-16, HB Value of 11-13 g/dL
|
11 Participants
|
19 Participants
|
10 Participants
|
17 Participants
|
17 Participants
|
13 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 13-16, HB Value of 10.5-13 g/dL
|
13 Participants
|
21 Participants
|
14 Participants
|
19 Participants
|
20 Participants
|
18 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-20, HB Value of 11-12 g/dL
|
4 Participants
|
9 Participants
|
9 Participants
|
11 Participants
|
9 Participants
|
9 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-20, HB Value of 11-13 g/dL
|
10 Participants
|
18 Participants
|
11 Participants
|
20 Participants
|
11 Participants
|
16 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-20, HB Value of 10.5-13 g/dL
|
11 Participants
|
19 Participants
|
17 Participants
|
20 Participants
|
17 Participants
|
19 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-24, HB Value of 11-12 g/dL
|
—
|
—
|
12 Participants
|
14 Participants
|
11 Participants
|
11 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-24, HB Value of 11-13 g/dL
|
—
|
—
|
13 Participants
|
20 Participants
|
12 Participants
|
17 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-24, HB Value of 10.5-13 g/dL
|
—
|
—
|
18 Participants
|
22 Participants
|
15 Participants
|
21 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 21-24, HB Value of 11-12 g/dL
|
—
|
—
|
11 Participants
|
13 Participants
|
7 Participants
|
14 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 21-24, HB Value of 11-13 g/dL
|
—
|
—
|
13 Participants
|
18 Participants
|
9 Participants
|
18 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 21-24, HB Value of 10.5-13 g/dL
|
—
|
—
|
19 Participants
|
21 Participants
|
13 Participants
|
20 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 25-28, HB Value of 11-12 g/dL
|
—
|
—
|
10 Participants
|
8 Participants
|
6 Participants
|
12 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 25-28, HB Value of 11-13 g/dL
|
—
|
—
|
11 Participants
|
11 Participants
|
9 Participants
|
13 Participants
|
|
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 25-28, HB Value of 10.5-13 g/dL
|
—
|
—
|
16 Participants
|
19 Participants
|
14 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=23 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=23 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 5-8, Hb Value of 11-12 g/dL
|
4 Participants
|
11 Participants
|
5 Participants
|
9 Participants
|
8 Participants
|
4 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 5-8, Hb Value of 11-13 g/dL
|
13 Participants
|
14 Participants
|
8 Participants
|
12 Participants
|
12 Participants
|
6 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 5-8, Hb Value of 10.5-13 g/dL
|
15 Participants
|
17 Participants
|
14 Participants
|
16 Participants
|
16 Participants
|
13 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-12, Hb Value of 11-12 g/dL
|
5 Participants
|
12 Participants
|
7 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-12, Hb Value of 11-13 g/dL
|
12 Participants
|
17 Participants
|
10 Participants
|
16 Participants
|
12 Participants
|
11 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-12, Hb Value of 10.5-13 g/dL
|
14 Participants
|
21 Participants
|
16 Participants
|
18 Participants
|
17 Participants
|
15 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-16, Hb Value of 11-12 g/dL
|
8 Participants
|
16 Participants
|
10 Participants
|
10 Participants
|
15 Participants
|
11 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-16, Hb Value of 11-13 g/dL
|
14 Participants
|
22 Participants
|
13 Participants
|
20 Participants
|
18 Participants
|
15 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-16, Hb Value of 10.5-13 g/dL
|
16 Participants
|
23 Participants
|
19 Participants
|
20 Participants
|
22 Participants
|
18 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 13-16, Hb Value of 11-12 g/dL
|
7 Participants
|
11 Participants
|
9 Participants
|
7 Participants
|
13 Participants
|
7 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 13-16, Hb Value of 11-13 g/dL
|
12 Participants
|
19 Participants
|
12 Participants
|
15 Participants
|
17 Participants
|
13 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 13-16, Hb Value of 10.5-13 g/dL
|
13 Participants
|
20 Participants
|
17 Participants
|
16 Participants
|
20 Participants
|
17 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-20, Hb Value of 11-12 g/dL
|
0 Participants
|
0 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-20, Hb Value of 11-13 g/dL
|
0 Participants
|
0 Participants
|
12 Participants
|
19 Participants
|
12 Participants
|
14 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-20, Hb Value of 10.5-13 g/dL
|
0 Participants
|
0 Participants
|
16 Participants
|
20 Participants
|
18 Participants
|
20 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-24, Hb Value of 11-12 g/dL
|
—
|
—
|
14 Participants
|
17 Participants
|
14 Participants
|
17 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-24, Hb Value of 11-13 g/dL
|
—
|
—
|
16 Participants
|
22 Participants
|
14 Participants
|
20 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-24, Hb Value of 10.5-13 g/dL
|
—
|
—
|
20 Participants
|
22 Participants
|
18 Participants
|
22 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 21-24, Hb Value of 11-12 g/dL
|
—
|
—
|
12 Participants
|
12 Participants
|
10 Participants
|
15 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 21-24, Hb Value of 11-13 g/dL
|
—
|
—
|
15 Participants
|
18 Participants
|
11 Participants
|
18 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 21-24, Hb Value of 10.5-13 g/dL
|
—
|
—
|
20 Participants
|
21 Participants
|
14 Participants
|
21 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 25-28, Hb Value of 11-12 g/dL
|
—
|
—
|
5 Participants
|
9 Participants
|
4 Participants
|
8 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 25-28, Hb Value of 11-13 g/dL
|
—
|
—
|
8 Participants
|
13 Participants
|
7 Participants
|
12 Participants
|
|
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Weeks 25-28, Hb Value of 10.5-13 g/dL
|
—
|
—
|
13 Participants
|
19 Participants
|
14 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
Participants can have a Hb value for the same category (11-12, 11-13, or 10.5-13 g/dL) reported for multiple weeks.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=23 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=23 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 11-12 g/dL by Week 5
|
9 Participants
|
11 Participants
|
5 Participants
|
8 Participants
|
11 Participants
|
10 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 11-12 g/dL by Week 9
|
11 Participants
|
16 Participants
|
11 Participants
|
11 Participants
|
15 Participants
|
14 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 11-12 g/dL by Week 13
|
11 Participants
|
19 Participants
|
14 Participants
|
13 Participants
|
17 Participants
|
17 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 11-12 g/dL by Week 17
|
12 Participants
|
20 Participants
|
16 Participants
|
14 Participants
|
17 Participants
|
20 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 11-12 g/dL by Week 21
|
—
|
—
|
17 Participants
|
15 Participants
|
19 Participants
|
22 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 11-12 g/dL by Week 25
|
—
|
—
|
21 Participants
|
18 Participants
|
20 Participants
|
22 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 11-13 g/dL by Week 5
|
16 Participants
|
14 Participants
|
6 Participants
|
14 Participants
|
13 Participants
|
10 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 11-13 g/dL by Week 9
|
18 Participants
|
21 Participants
|
14 Participants
|
19 Participants
|
18 Participants
|
14 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 11-13 g/dL by Week 13
|
18 Participants
|
23 Participants
|
17 Participants
|
21 Participants
|
21 Participants
|
17 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 11-13 g/dL by Week 17
|
19 Participants
|
24 Participants
|
19 Participants
|
22 Participants
|
23 Participants
|
21 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 11-13 g/dL by Week 21
|
—
|
—
|
20 Participants
|
22 Participants
|
23 Participants
|
22 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 11-13 g/dL by Week 25
|
—
|
—
|
22 Participants
|
23 Participants
|
23 Participants
|
22 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 10.5-13 g/dL by Week 5
|
17 Participants
|
20 Participants
|
12 Participants
|
17 Participants
|
17 Participants
|
14 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 10.5-13 g/dL by Week 9
|
19 Participants
|
22 Participants
|
19 Participants
|
21 Participants
|
19 Participants
|
19 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 10.5-13 g/dL by Week 13
|
19 Participants
|
23 Participants
|
20 Participants
|
23 Participants
|
22 Participants
|
21 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 10.5-13 g/dL by Week 17
|
20 Participants
|
24 Participants
|
21 Participants
|
23 Participants
|
23 Participants
|
23 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 10.5-13 g/dL by Week 21
|
—
|
—
|
22 Participants
|
24 Participants
|
23 Participants
|
23 Participants
|
|
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Hb Value of 10.5-13 g/dL by Week 25
|
—
|
—
|
23 Participants
|
24 Participants
|
23 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=23 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=23 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 25-28, Hb Value of 13-14 g/dL
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 5-8, Hb Value of <11 g/dL
|
6 Participants
|
9 Participants
|
10 Participants
|
5 Participants
|
6 Participants
|
13 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 5-8, Hb Value of 12-13 g/dL
|
10 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 5-8, Hb Value of 13-14 g/dL
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 5-8, Hb Value of >14 g/dL
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-12, Hb Value of <11 g/dL
|
4 Participants
|
2 Participants
|
9 Participants
|
4 Participants
|
7 Participants
|
11 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-12, Hb Value of 12-13 g/dL
|
5 Participants
|
9 Participants
|
4 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-12, Hb Value of 13-14 g/dL
|
7 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-12, Hb Value of >14 g/dL
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-16, Hb Value of <11 g/dL
|
4 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-16, Hb Value of 12-13 g/dL
|
4 Participants
|
10 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-16, Hb Value of 13-14 g/dL
|
7 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 9-16, Hb Value of >14 g/dL
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 13-16, Hb Value of <11 g/dL
|
5 Participants
|
2 Participants
|
9 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 13-16, Hb Value of 12-13 g/dL
|
4 Participants
|
9 Participants
|
4 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 13-16, Hb Value of 13-14 g/dL
|
6 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 13-16, Hb Value of >14 g/dL
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-20, Hb Value of <11 g/dL
|
4 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-20, Hb Value of 12-13 g/dL
|
6 Participants
|
9 Participants
|
4 Participants
|
10 Participants
|
5 Participants
|
5 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-20, Hb Value of 13-14 g/dL
|
6 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-20, Hb Value of >14 g/dL
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-24, Hb Value of <11 g/dL
|
—
|
—
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-24, Hb Value of 12-13 g/dL
|
—
|
—
|
8 Participants
|
13 Participants
|
6 Participants
|
7 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-24, Hb Value of 13-14 g/dL
|
—
|
—
|
1 Participants
|
6 Participants
|
0 Participants
|
4 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 17-24, Hb Value of >14 g/dL
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 21-24, Hb Value of <11 g/dL
|
—
|
—
|
2 Participants
|
1 Participants
|
9 Participants
|
4 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 21-24, Hb Value of 12-13 g/dL
|
—
|
—
|
6 Participants
|
10 Participants
|
3 Participants
|
7 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 21-24, Hb Value of 13-14 g/dL
|
—
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 21-24, Hb Value of >14 g/dL
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 25-28, Hb Value of <11 g/dL
|
—
|
—
|
7 Participants
|
6 Participants
|
7 Participants
|
8 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 25-28, Hb Value of 12-13 g/dL
|
—
|
—
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Weeks 25-28, Hb Value of >14 g/dL
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study.
Median time to response was estimated using Kaplan Meier method, Cohort A and B censored at Week 17, Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=23 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=23 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL
|
28.0 days
Interval 28.0 to 56.0
|
28.0 days
Interval 28.0 to 56.0
|
48.9 days
Interval 28.0 to 56.0
|
28.0 days
Interval 28.0 to 56.0
|
35.0 days
Interval 28.0 to 56.0
|
56.0 days
Interval 28.0 to 56.0
|
SECONDARY outcome
Timeframe: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study.
Median time to response was estimated using Kaplan Meier method; Cohort A and B censored at Week 17 and Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=23 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=23 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline
|
21.0 days
Interval 21.0 to 42.0
|
21.6 days
Interval 21.0 to 42.0
|
42.0 days
Interval 21.0 to 42.0
|
21.0 days
Interval 21.0 to 42.0
|
35.0 days
Interval 21.0 to 42.0
|
42.0 days
Interval 21.0 to 42.0
|
SECONDARY outcome
Timeframe: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=23 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=23 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline
|
2.30 mg/kg/week
Interval 0.6 to 6.4
|
2.50 mg/kg/week
Interval 1.4 to 4.4
|
2.32 mg/kg/week
Interval 0.7 to 6.6
|
2.36 mg/kg/week
Interval 0.8 to 6.5
|
1.96 mg/kg/week
Interval 0.5 to 4.9
|
1.61 mg/kg/week
Interval 0.8 to 4.6
|
SECONDARY outcome
Timeframe: Cohorts A and B: Weekly through Week 16 (end of treatment), Week 18 (2 weeks posttreatment), and Week 20 (4 weeks posttreatment); Cohorts C-F: Weekly through Week 24 (end of treatment), Week 26 (2 weeks posttreatment), and Week 28 (4 weeks posttreatment)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=19 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=21 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=23 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=23 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=21 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 18 weeks
|
—
|
—
|
-0.06 g/dL
Standard Deviation 0.704
|
0.39 g/dL
Standard Deviation 0.763
|
-0.44 g/dL
Standard Deviation 0.699
|
0.27 g/dL
Standard Deviation 0.405
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 4 weeks posttreatment
|
0.21 g/dL
Standard Deviation 1.289
|
-0.28 g/dL
Standard Deviation 0.902
|
-0.62 g/dL
Standard Deviation 0.846
|
-0.80 g/dL
Standard Deviation 0.708
|
-0.99 g/dL
Standard Deviation 1.296
|
-0.79 g/dL
Standard Deviation 0.777
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Hb at Response Timepoint
|
11.49 g/dL
Standard Deviation 0.414
|
11.40 g/dL
Standard Deviation 0.289
|
11.32 g/dL
Standard Deviation 0.360
|
11.47 g/dL
Standard Deviation 0.430
|
11.62 g/dL
Standard Deviation 0.543
|
11.43 g/dL
Standard Deviation 0.348
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 1 week
|
0.30 g/dL
Standard Deviation 0.579
|
0.03 g/dL
Standard Deviation 0.562
|
-0.18 g/dL
Standard Deviation 0.854
|
0.18 g/dL
Standard Deviation 0.570
|
-0.26 g/dL
Standard Deviation 0.709
|
-0.23 g/dL
Standard Deviation 0.394
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 2 weeks
|
0.46 g/dL
Standard Deviation 0.685
|
0.05 g/dL
Standard Deviation 0.634
|
-0.22 g/dL
Standard Deviation 0.868
|
0.41 g/dL
Standard Deviation 0.678
|
-0.34 g/dL
Standard Deviation 0.720
|
-0.21 g/dL
Standard Deviation 0.707
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 3 weeks
|
0.67 g/dL
Standard Deviation 0.635
|
0.19 g/dL
Standard Deviation 0.720
|
-0.02 g/dL
Standard Deviation 0.842
|
0.44 g/dL
Standard Deviation 0.873
|
-0.31 g/dL
Standard Deviation 0.934
|
-0.25 g/dL
Standard Deviation 0.682
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 4 weeks
|
0.81 g/dL
Standard Deviation 0.642
|
0.17 g/dL
Standard Deviation 0.968
|
0.06 g/dL
Standard Deviation 0.767
|
0.61 g/dL
Standard Deviation 0.859
|
-0.18 g/dL
Standard Deviation 1.080
|
-0.24 g/dL
Standard Deviation 0.794
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 5 weeks
|
0.99 g/dL
Standard Deviation 0.705
|
0.20 g/dL
Standard Deviation 1.004
|
-0.07 g/dL
Standard Deviation 0.701
|
0.65 g/dL
Standard Deviation 0.883
|
-0.05 g/dL
Standard Deviation 1.295
|
0.13 g/dL
Standard Deviation 0.752
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 6 weeks
|
1.01 g/dL
Standard Deviation 0.999
|
0.23 g/dL
Standard Deviation 0.931
|
0.02 g/dL
Standard Deviation 0.821
|
0.67 g/dL
Standard Deviation 0.799
|
0.10 g/dL
Standard Deviation 1.274
|
-0.01 g/dL
Standard Deviation 0.937
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 7 weeks
|
0.97 g/dL
Standard Deviation 0.874
|
0.21 g/dL
Standard Deviation 0.860
|
0.40 g/dL
Standard Deviation 0.876
|
0.87 g/dL
Standard Deviation 0.882
|
-0.21 g/dL
Standard Deviation 1.255
|
0.03 g/dL
Standard Deviation 0.830
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 8 weeks
|
1.05 g/dL
Standard Deviation 0.852
|
0.45 g/dL
Standard Deviation 0.827
|
0.18 g/dL
Standard Deviation 0.820
|
0.78 g/dL
Standard Deviation 0.820
|
-0.15 g/dL
Standard Deviation 1.238
|
-0.03 g/dL
Standard Deviation 1.005
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 9 weeks
|
0.88 g/dL
Standard Deviation 0.904
|
0.59 g/dL
Standard Deviation 0.898
|
0.22 g/dL
Standard Deviation 1.131
|
0.79 g/dL
Standard Deviation 0.960
|
-0.43 g/dL
Standard Deviation 1.075
|
-0.03 g/dL
Standard Deviation 0.944
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 10 weeks
|
0.88 g/dL
Standard Deviation 1.044
|
0.68 g/dL
Standard Deviation 0.787
|
0.44 g/dL
Standard Deviation 1.109
|
1.01 g/dL
Standard Deviation 0.629
|
-0.22 g/dL
Standard Deviation 1.226
|
0.26 g/dL
Standard Deviation 1.018
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 11 weeks
|
0.89 g/dL
Standard Deviation 1.088
|
0.59 g/dL
Standard Deviation 0.644
|
0.39 g/dL
Standard Deviation 0.972
|
0.82 g/dL
Standard Deviation 0.678
|
-0.42 g/dL
Standard Deviation 0.966
|
0.09 g/dL
Standard Deviation 0.974
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 12 weeks
|
0.91 g/dL
Standard Deviation 1.007
|
0.69 g/dL
Standard Deviation 0.474
|
0.25 g/dL
Standard Deviation 0.966
|
0.60 g/dL
Standard Deviation 0.745
|
-0.38 g/dL
Standard Deviation 0.818
|
0.21 g/dL
Standard Deviation 0.774
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 13 weeks
|
1.53 g/dL
Standard Deviation 0.962
|
0.90 g/dL
Standard Deviation 0.837
|
0.13 g/dL
Standard Deviation 1.010
|
0.45 g/dL
Standard Deviation 0.808
|
-0.58 g/dL
Standard Deviation 0.946
|
0.33 g/dL
Standard Deviation 0.880
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 14 weeks
|
2.16 g/dL
Standard Deviation 0.385
|
0.94 g/dL
Standard Deviation 0.976
|
0.18 g/dL
Standard Deviation 0.913
|
0.37 g/dL
Standard Deviation 0.874
|
-0.65 g/dL
Standard Deviation 1.079
|
0.41 g/dL
Standard Deviation 0.778
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 15 weeks
|
1.20 g/dL
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
1.50 g/dL
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
0.13 g/dL
Standard Deviation 0.751
|
0.32 g/dL
Standard Deviation 0.815
|
-0.67 g/dL
Standard Deviation 1.191
|
0.18 g/dL
Standard Deviation 0.636
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 16 weeks
|
—
|
—
|
0.08 g/dL
Standard Deviation 0.851
|
0.21 g/dL
Standard Deviation 0.808
|
-0.68 g/dL
Standard Deviation 1.262
|
0.41 g/dL
Standard Deviation 0.524
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 17 weeks
|
—
|
—
|
0.12 g/dL
Standard Deviation 0.529
|
0.18 g/dL
Standard Deviation 0.718
|
-0.52 g/dL
Standard Deviation 0.984
|
0.47 g/dL
Standard Deviation 0.751
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 19 weeks
|
—
|
—
|
-0.20 g/dL
Standard Deviation 0.807
|
0.33 g/dL
Standard Deviation 0.855
|
-0.31 g/dL
Standard Deviation 0.888
|
0.26 g/dL
Standard Deviation 0.821
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 20 weeks
|
—
|
—
|
-0.50 g/dL
Standard Deviation 0.283
|
-0.12 g/dL
Standard Deviation 1.035
|
-0.43 g/dL
Standard Deviation 1.275
|
0.51 g/dL
Standard Deviation 0.839
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 21 weeks
|
—
|
—
|
0.20 g/dL
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
-0.49 g/dL
Standard Deviation 1.146
|
-0.40 g/dL
Standard Deviation 0.849
|
0.37 g/dL
Standard Deviation 0.737
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 22 weeks
|
—
|
—
|
0.90 g/dL
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
-1.05 g/dL
Standard Deviation 0.480
|
-0.33 g/dL
Standard Deviation 0.839
|
0.15 g/dL
Standard Deviation 0.354
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 23 weeks
|
—
|
—
|
—
|
-1.10 g/dL
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
-0.90 g/dL
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
—
|
|
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Change after 2 weeks posttreatment
|
0.49 g/dL
Standard Deviation 1.113
|
0.21 g/dL
Standard Deviation 0.985
|
-0.28 g/dL
Standard Deviation 0.614
|
-0.25 g/dL
Standard Deviation 0.924
|
-0.61 g/dL
Standard Deviation 1.023
|
-0.34 g/dL
Standard Deviation 0.562
|
SECONDARY outcome
Timeframe: Cohorts A and B: Weekly through Week 16 (end of treatment [EoT]) and Week 20 (Follow up [4 weeks posttreatment]); Cohorts C-F: Weekly through Week 24 (EoT) and Week 28 (Follow up [4 weeks posttreatment])Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=19 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=23 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=22 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=23 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=23 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=22 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories
After Response through EoT, Hb Category <11 g/dL
|
11.50 g/dL
Standard Deviation 25.937
|
18.75 g/dL
Standard Deviation 27.254
|
35.48 g/dL
Standard Deviation 32.727
|
14.03 g/dL
Standard Deviation 18.311
|
38.32 g/dL
Standard Deviation 30.175
|
32.56 g/dL
Standard Deviation 33.384
|
|
Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories
After Response through EoT, Hb Category 11-12 g/dL
|
31.46 g/dL
Standard Deviation 30.410
|
48.86 g/dL
Standard Deviation 26.771
|
46.67 g/dL
Standard Deviation 29.540
|
41.54 g/dL
Standard Deviation 26.619
|
44.17 g/dL
Standard Deviation 22.858
|
47.00 g/dL
Standard Deviation 27.692
|
|
Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories
After Response through EoT, Hb Category 11-13 g/dL
|
66.73 g/dL
Standard Deviation 27.453
|
76.05 g/dL
Standard Deviation 26.577
|
62.10 g/dL
Standard Deviation 31.528
|
74.96 g/dL
Standard Deviation 24.078
|
56.92 g/dL
Standard Deviation 27.338
|
64.39 g/dL
Standard Deviation 32.083
|
|
Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories
After Response through EoT, Hb Category 10.5-13 g/dL
|
76.80 g/dL
Standard Deviation 23.899
|
87.20 g/dL
Standard Deviation 20.118
|
82.69 g/dL
Standard Deviation 25.854
|
83.50 g/dL
Standard Deviation 21.354
|
79.01 g/dL
Standard Deviation 23.045
|
83.97 g/dL
Standard Deviation 26.219
|
|
Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories
In Follow Up, Hb Category <11 g/dL
|
16.67 g/dL
Standard Deviation 34.300
|
35.71 g/dL
Standard Deviation 42.258
|
54.76 g/dL
Standard Deviation 41.547
|
47.83 g/dL
Standard Deviation 43.896
|
57.50 g/dL
Standard Deviation 43.755
|
50.00 g/dL
Standard Deviation 44.096
|
|
Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories
In Follow Up, Hb Category 11-12 g/dL
|
30.56 g/dL
Standard Deviation 38.877
|
40.48 g/dL
Standard Deviation 40.679
|
40.48 g/dL
Standard Deviation 40.679
|
41.30 g/dL
Standard Deviation 38.883
|
30.00 g/dL
Standard Deviation 37.697
|
47.37 g/dL
Standard Deviation 42.406
|
|
Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories
In Follow Up, Hb Category 11-13 g/dL
|
69.44 g/dL
Standard Deviation 42.492
|
59.52 g/dL
Standard Deviation 40.679
|
45.24 g/dL
Standard Deviation 41.547
|
52.17 g/dL
Standard Deviation 43.896
|
42.50 g/dL
Standard Deviation 43.755
|
50.00 g/dL
Standard Deviation 44.096
|
|
Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories
In Follow Up, Hb Category 10.5-13 g/dL
|
75.00 g/dL
Standard Deviation 39.295
|
83.33 g/dL
Standard Deviation 32.914
|
66.67 g/dL
Standard Deviation 36.515
|
71.74 g/dL
Standard Deviation 39.388
|
65.00 g/dL
Standard Deviation 43.225
|
73.68 g/dL
Standard Deviation 34.835
|
SECONDARY outcome
Timeframe: Weeks 13-17 (all cohorts) and 18-25 (24-week treatment cohorts only)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. LOCF method was used to impute missing values.
The mean percentage of the scheduled weekly Hb values that were \<10.5, \>13, and \>14 g/dL during Weeks 13-17 and 18-25 is presented.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=22 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=23 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=23 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=22 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=24 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25
Weeks 13-17, Hb <10.5 g/dL
|
15.23 percentage of Hb values
Standard Deviation 33.893
|
7.92 percentage of Hb values
Standard Deviation 20.212
|
25.65 percentage of Hb values
Standard Deviation 36.752
|
9.78 percentage of Hb values
Standard Deviation 24.885
|
9.17 percentage of Hb values
Standard Deviation 19.174
|
22.75 percentage of Hb values
Standard Deviation 35.995
|
|
Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25
Weeks 13-17, Hb >13 g/dL
|
25.00 percentage of Hb values
Standard Deviation 37.257
|
7.50 percentage of Hb values
Standard Deviation 17.508
|
4.35 percentage of Hb values
Standard Deviation 14.717
|
18.26 percentage of Hb values
Standard Deviation 31.283
|
2.95 percentage of Hb values
Standard Deviation 7.662
|
0.87 percentage of Hb values
Standard Deviation 4.170
|
|
Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25
Weeks 13-17, Hb >14 g/dL
|
2.73 percentage of Hb values
Standard Deviation 9.351
|
0 percentage of Hb values
Standard Deviation 0
|
0 percentage of Hb values
Standard Deviation 0
|
0.87 percentage of Hb values
Standard Deviation 4.170
|
0 percentage of Hb values
Standard Deviation 0
|
0 percentage of Hb values
Standard Deviation 0
|
|
Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25
Weeks 18-25, Hb <10.5 g/dL
|
—
|
—
|
21.97 percentage of Hb values
Standard Deviation 31.809
|
9.38 percentage of Hb values
Standard Deviation 22.797
|
23.86 percentage of Hb values
Standard Deviation 33.830
|
16.84 percentage of Hb values
Standard Deviation 31.625
|
|
Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25
Weeks 18-25, Hb >13 g/dL
|
—
|
—
|
2.17 percentage of Hb values
Standard Deviation 10.426
|
5.00 percentage of Hb values
Standard Deviation 16.219
|
3.41 percentage of Hb values
Standard Deviation 15.990
|
3.13 percentage of Hb values
Standard Deviation 7.599
|
|
Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25
Weeks 18-25, Hb >14 g/dL
|
—
|
—
|
0 percentage of Hb values
Standard Deviation 0
|
0 percentage of Hb values
Standard Deviation 0
|
0.57 percentage of Hb values
Standard Deviation 2.665
|
0 percentage of Hb values
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline up to Week 28 (end of study)Population: Safety Population included all participants who received any dose of study drug.
Rescue treatment included recombinant erythropoiesis-stimulating agent (ESA), red blood cell transfusion (in the absence of a known bleeding episode or surgical blood loss), or intravenous (IV) Iron
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=24 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=24 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Number (%) of Participants Requiring Rescue Therapy
Blood Transfusion
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number (%) of Participants Requiring Rescue Therapy
ESA
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number (%) of Participants Requiring Rescue Therapy
IV Iron
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 28 (end of study)Population: Safety Population included all participants who received any dose of study drug.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=24 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=24 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Number (%) of Participants Requiring Therapeutic Phlebotomy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 28 (end of study)Population: Safety Population included all participants who received any dose of study drug.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=24 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=24 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 1-4, 5-12, and 13-16 (all cohorts) and Weeks 17-24 (24-week treatment cohorts only)Population: Safety Population included all participants who received any dose of study drug. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
Dose changes include dose reductions, dose increases, and dose holds.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=24 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=24 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=24 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose reduced, Weeks 1-4
|
5 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose reduced, Weeks 5-12
|
13 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
|
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose reduced, Weeks 13-16
|
0 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose reduced, Weeks 17-24
|
—
|
—
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose increased, Weeks 1-4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose increased, Weeks 5-12
|
10 Participants
|
11 Participants
|
14 Participants
|
9 Participants
|
9 Participants
|
15 Participants
|
|
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose increased, Weeks 13-16
|
4 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose increased, Weeks 17-24
|
—
|
—
|
2 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose held, Weeks 1-4
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose held, Weeks 5-12
|
5 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose held, Weeks 13-16
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose held, Weeks 17-24
|
—
|
—
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=19 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=21 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=23 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=23 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=21 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
Weekly Dose
|
4.08 mg/kg
Standard Deviation 0.952
|
4.13 mg/kg
Standard Deviation 0.944
|
2.88 mg/kg
Standard Deviation 1.721
|
4.17 mg/kg
Standard Deviation 1.119
|
2.65 mg/kg
Standard Deviation 0.886
|
3.02 mg/kg
Standard Deviation 0.876
|
|
Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
Cumulative Dose
|
16.86 mg/kg
Standard Deviation 17.097
|
20.05 mg/kg
Standard Deviation 15.994
|
24.41 mg/kg
Standard Deviation 23.838
|
21.21 mg/kg
Standard Deviation 18.229
|
16.57 mg/kg
Standard Deviation 12.154
|
22.16 mg/kg
Standard Deviation 17.612
|
SECONDARY outcome
Timeframe: Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)Population: Safety Population included all participants who received any dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=18 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=23 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=20 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=23 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=22 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=20 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
6 weeks after response
|
2.09 mg/kg
Standard Deviation 0.82
|
2.75 mg/kg
Standard Deviation 0.87
|
2.57 mg/kg
Standard Deviation 1.47
|
3.48 mg/kg
Standard Deviation 1.30
|
1.99 mg/kg
Standard Deviation 0.98
|
2.53 mg/kg
Standard Deviation 1.16
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
9 weeks after response
|
2.01 mg/kg
Standard Deviation 0.88
|
2.71 mg/kg
Standard Deviation 1.08
|
2.35 mg/kg
Standard Deviation 1.22
|
3.16 mg/kg
Standard Deviation 1.43
|
2.15 mg/kg
Standard Deviation 1.08
|
2.23 mg/kg
Standard Deviation 0.86
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
10 weeks after response
|
2.15 mg/kg
Standard Deviation 0.79
|
2.59 mg/kg
Standard Deviation 1.00
|
2.18 mg/kg
Standard Deviation 1.29
|
2.96 mg/kg
Standard Deviation 1.36
|
2.13 mg/kg
Standard Deviation 1.09
|
2.16 mg/kg
Standard Deviation 0.89
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
11 weeks after response
|
2.13 mg/kg
Standard Deviation 0.85
|
2.72 mg/kg
Standard Deviation 1.16
|
2.18 mg/kg
Standard Deviation 1.29
|
2.77 mg/kg
Standard Deviation 1.30
|
2.02 mg/kg
Standard Deviation 0.89
|
2.14 mg/kg
Standard Deviation 0.93
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
12 weeks after response
|
2.07 mg/kg
Standard Deviation 0.75
|
2.81 mg/kg
Standard Deviation 0.97
|
2.19 mg/kg
Standard Deviation 1.34
|
2.65 mg/kg
Standard Deviation 1.40
|
1.89 mg/kg
Standard Deviation 0.93
|
1.87 mg/kg
Standard Deviation 0.82
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
13 weeks after response
|
1.72 mg/kg
Standard Deviation 0.85
|
2.70 mg/kg
Standard Deviation 0.43
|
2.19 mg/kg
Standard Deviation 1.34
|
2.65 mg/kg
Standard Deviation 1.42
|
1.70 mg/kg
Standard Deviation 0.58
|
1.95 mg/kg
Standard Deviation 0.83
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
14 weeks after response
|
—
|
2.87 mg/kg
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
2.04 mg/kg
Standard Deviation 1.42
|
2.69 mg/kg
Standard Deviation 1.52
|
1.71 mg/kg
Standard Deviation 0.54
|
1.83 mg/kg
Standard Deviation 0.87
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
15 weeks after response
|
—
|
—
|
2.04 mg/kg
Standard Deviation 1.44
|
2.68 mg/kg
Standard Deviation 1.51
|
1.70 mg/kg
Standard Deviation 0.56
|
1.85 mg/kg
Standard Deviation 0.91
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
16 weeks after response
|
—
|
—
|
2.04 mg/kg
Standard Deviation 1.44
|
2.72 mg/kg
Standard Deviation 1.62
|
1.66 mg/kg
Standard Deviation 0.53
|
1.76 mg/kg
Standard Deviation 0.72
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
17 weeks after response
|
—
|
—
|
2.13 mg/kg
Standard Deviation 1.46
|
2.51 mg/kg
Standard Deviation 1.67
|
1.66 mg/kg
Standard Deviation 0.50
|
1.82 mg/kg
Standard Deviation 0.89
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
18 weeks after response
|
—
|
—
|
1.53 mg/kg
Standard Deviation 0.66
|
2.43 mg/kg
Standard Deviation 1.79
|
1.57 mg/kg
Standard Deviation 0.50
|
1.83 mg/kg
Standard Deviation 0.94
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
19 weeks after response
|
—
|
—
|
1.25 mg/kg
Standard Deviation 0.39
|
2.51 mg/kg
Standard Deviation 1.94
|
1.63 mg/kg
Standard Deviation 0.58
|
1.89 mg/kg
Standard Deviation 0.98
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
20 weeks after response
|
—
|
—
|
—
|
1.82 mg/kg
Standard Deviation 1.29
|
1.49 mg/kg
Standard Deviation 0.70
|
1.36 mg/kg
Standard Deviation 0.40
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
21 weeks after response
|
—
|
—
|
1.65 mg/kg
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
1.13 mg/kg
Standard Deviation 0.42
|
1.36 mg/kg
Standard Deviation 0.80
|
1.28 mg/kg
Standard Deviation 0.24
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
22 weeks after response
|
—
|
—
|
—
|
0.85 mg/kg
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
2.04 mg/kg
Standard Deviation NA
NA=Standard Deviation cannot be calculated with N of 1.
|
—
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
1 week after response
|
2.99 mg/kg
Standard Deviation 1.16
|
3.05 mg/kg
Standard Deviation 1.13
|
2.73 mg/kg
Standard Deviation 1.56
|
3.87 mg/kg
Standard Deviation 1.28
|
2.09 mg/kg
Standard Deviation 0.89
|
2.59 mg/kg
Standard Deviation 0.90
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
2 weeks after response
|
2.64 mg/kg
Standard Deviation 1.14
|
2.86 mg/kg
Standard Deviation 1.13
|
2.63 mg/kg
Standard Deviation 1.39
|
3.85 mg/kg
Standard Deviation 1.08
|
1.97 mg/kg
Standard Deviation 0.92
|
2.50 mg/kg
Standard Deviation 1.02
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
3 weeks after response
|
2.50 mg/kg
Standard Deviation 0.84
|
2.86 mg/kg
Standard Deviation 1.06
|
2.63 mg/kg
Standard Deviation 1.39
|
3.53 mg/kg
Standard Deviation 1.13
|
1.92 mg/kg
Standard Deviation 0.87
|
2.47 mg/kg
Standard Deviation 0.99
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
4 weeks after response
|
2.18 mg/kg
Standard Deviation 0.82
|
2.82 mg/kg
Standard Deviation 0.91
|
2.44 mg/kg
Standard Deviation 1.13
|
3.81 mg/kg
Standard Deviation 1.36
|
1.96 mg/kg
Standard Deviation 0.95
|
2.62 mg/kg
Standard Deviation 1.14
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
5 weeks after response
|
2.32 mg/kg
Standard Deviation 0.75
|
2.73 mg/kg
Standard Deviation 0.86
|
2.54 mg/kg
Standard Deviation 1.52
|
3.61 mg/kg
Standard Deviation 1.49
|
1.97 mg/kg
Standard Deviation 0.96
|
2.57 mg/kg
Standard Deviation 1.05
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
7 weeks after response
|
2.03 mg/kg
Standard Deviation 0.69
|
2.76 mg/kg
Standard Deviation 0.90
|
2.65 mg/kg
Standard Deviation 1.51
|
3.31 mg/kg
Standard Deviation 1.29
|
1.99 mg/kg
Standard Deviation 1.00
|
2.33 mg/kg
Standard Deviation 0.94
|
|
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
8 weeks after response
|
2.01 mg/kg
Standard Deviation 0.78
|
2.84 mg/kg
Standard Deviation 0.96
|
2.60 mg/kg
Standard Deviation 1.54
|
3.21 mg/kg
Standard Deviation 1.33
|
2.07 mg/kg
Standard Deviation 1.07
|
2.14 mg/kg
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment)Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. Last-observation-carried-forward (LOCF) method was used to impute missing values.
Baseline was defined as the mean of the last 3 available values predose.
Outcome measures
| Measure |
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=17 Participants
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=11 Participants
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=10 Participants
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort D: Roxadustat at 100 mg TIW
n=14 Participants
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=9 Participants
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=13 Participants
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24
Baseline
|
9.62 g/dL
Standard Deviation 0.92
|
9.56 g/dL
Standard Deviation 0.43
|
9.68 g/dL
Standard Deviation 0.41
|
9.58 g/dL
Standard Deviation 0.86
|
9.96 g/dL
Standard Deviation 0.51
|
9.75 g/dL
Standard Deviation 0.63
|
|
Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24
Change at Week 16
|
2.42 g/dL
Standard Deviation 1.12
|
2.32 g/dL
Standard Deviation 1.00
|
1.85 g/dL
Standard Deviation 1.34
|
2.21 g/dL
Standard Deviation 1.42
|
1.37 g/dL
Standard Deviation 0.68
|
1.42 g/dL
Standard Deviation 1.01
|
|
Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24
Change at Week 24
|
—
|
—
|
1.66 g/dL
Standard Deviation 0.45
|
1.75 g/dL
Standard Deviation 1.14
|
1.09 g/dL
Standard Deviation 0.82
|
1.53 g/dL
Standard Deviation 0.88
|
Adverse Events
Cohort D: Roxadustat at 100 mg TIW
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort C: Roxadustat at 50 mg TIW
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
Serious events: 10 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort F: Roxadustat at 70 mg BIW Then QW
Serious events: 10 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort D: Roxadustat at 100 mg TIW
n=24 participants at risk
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=24 participants at risk
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 participants at risk
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=24 participants at risk
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 participants at risk
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 participants at risk
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
12.0%
3/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Renal and urinary disorders
Renal Failure Chronic
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Diabetic Gastroparesis
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.0%
2/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Infections and infestations
Abscess
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemic Hyperosmolar Nonketotic Syndrome
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Nervous system disorders
Brain Stem Infarction
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Nervous system disorders
Cerebellar Infarction
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Foreign Body
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
General disorders
Death
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
Other adverse events
| Measure |
Cohort D: Roxadustat at 100 mg TIW
n=24 participants at risk
Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
n=24 participants at risk
Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
|
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW
n=24 participants at risk
Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
|
Cohort C: Roxadustat at 50 mg TIW
n=24 participants at risk
Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
|
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW
n=24 participants at risk
Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
|
Cohort F: Roxadustat at 70 mg BIW Then QW
n=25 participants at risk
Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
12.5%
3/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
16.7%
4/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
16.7%
4/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
16.7%
4/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
12.0%
3/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
12.5%
3/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.0%
2/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
12.5%
3/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
3/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
16.7%
4/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
20.8%
5/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
12.5%
3/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
12.5%
3/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
General disorders
Oedema Peripheral
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
20.8%
5/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
16.7%
4/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
16.0%
4/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
12.5%
3/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
12.5%
3/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
0.00%
0/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
|
Vascular disorders
Hypertension
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
16.7%
4/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.2%
1/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
8.3%
2/24 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
4.0%
1/25 • Baseline up to Week 28 (end of study)
Safety Population included all participants who received any dose of study drug.
|
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
Restriction type: OTHER