Trial Outcomes & Findings for Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID) (NCT NCT03029208)
NCT ID: NCT03029208
Last Updated: 2021-10-20
Results Overview
Blood samples were collected from participants for Hgb measurement. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputations. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. An analysis of covariance (ANCOVA) model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95 percent (%) confidence interval (CI) for the treatment difference (daprodustat-darbepoetin alfa).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
312 participants
Primary outcome timeframe
Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)
Results posted on
2021-10-20
Participant Flow
This was a multicenter study conducted across 14 countries. Participants were randomized to receive either Daprodustat or Darbepoetin alfa.
A total of 312 participants were randomized in the study.
Participant milestones
| Measure |
Daprodustat
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
155
|
|
Overall Study
COMPLETED
|
155
|
151
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Daprodustat
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)
Baseline characteristics by cohort
| Measure |
Daprodustat
n=157 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=155 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.7 Years
STANDARD_DEVIATION 14.31 • n=5 Participants
|
55.8 Years
STANDARD_DEVIATION 15.70 • n=7 Participants
|
54.7 Years
STANDARD_DEVIATION 15.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian (AI) or Alaskan Native (AN)
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian: Central/South Asian Heritage
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian: East Asian Heritage
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian: South East Asian Heritage
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White: Arabic/North African Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White: White/Caucasian/European Heritage
|
109 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed race: AI or AN and White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)Population: Intent-to-Treat (ITT) Population comprised all randomized participants (who received a treatment randomization number).
Blood samples were collected from participants for Hgb measurement. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputations. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. An analysis of covariance (ANCOVA) model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95 percent (%) confidence interval (CI) for the treatment difference (daprodustat-darbepoetin alfa).
Outcome measures
| Measure |
Daprodustat
n=157 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=155 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52)
|
1.02 Grams per deciliter
Standard Error 0.086
|
1.12 Grams per deciliter
Standard Error 0.085
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
Total IV iron dose per participant was calculated from Day 1 to the earliest of (Week 52 visit date, first blood \[red blood cells or whole blood\] transfusion date and treatment stop date plus \[+\] 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. Average monthly IV iron dose was calculated by Total IV iron dose divided by (/) (the number of days from Day 1 to the earliest of \[Week 52 visit date, first blood transfusion date and treatment stop date +1\] /30.4375 days). Data for participants until they underwent a red blood cells or whole blood transfusion was included in the analysis.
Outcome measures
| Measure |
Daprodustat
n=156 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=154 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52
|
144.7 Milligram
Standard Error 10.90
|
125.3 Milligram
Standard Error 10.97
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using mixed model repeated measures (MMRM) model.
Outcome measures
| Measure |
Daprodustat
n=153 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=149 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52
SBP
|
-3.57 Millimeter of mercury
Standard Error 2.063
|
-6.80 Millimeter of mercury
Standard Error 2.931
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52
DBP
|
0.21 Millimeter of mercury
Standard Error 1.216
|
-4.01 Millimeter of mercury
Standard Error 1.650
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52
MAP
|
-0.95 Millimeter of mercury
Standard Error 1.364
|
-5.05 Millimeter of mercury
Standard Error 1.894
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (last on-treatment value until Week 52)Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. End of treatment value for the blood pressure parameters were defined as the latest value on or before the last non-zero dose date plus (+) 1 day. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using ANCOVA model.
Outcome measures
| Measure |
Daprodustat
n=154 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=153 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in SBP, DBP, MAP at End of Treatment
SBP
|
-3.23 Millimeter of mercury
Standard Error 1.659
|
-3.14 Millimeter of mercury
Standard Error 1.664
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SBP, DBP, MAP at End of Treatment
DBP
|
0.60 Millimeter of mercury
Standard Error 1.016
|
-1.39 Millimeter of mercury
Standard Error 1.020
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SBP, DBP, MAP at End of Treatment
MAP
|
-0.68 Millimeter of mercury
Standard Error 1.092
|
-1.97 Millimeter of mercury
Standard Error 1.096
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
BP exacerbation event is defined (based on post-dialysis BP) as SBP \>=25 millimeter of mercury (mmHg) increased from Baseline or SBP \>=180 mmHg; or DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model.
Outcome measures
| Measure |
Daprodustat
n=155 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=154 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years
|
352.50 Events per 100 participant year
Interval 268.89 to 462.09
|
350.00 Events per 100 participant year
Interval 267.72 to 457.56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
BP exacerbation was defined (based on post-dialysis BP) as: SBP \>=25 mmHg increased from Baseline or SBP \>=180 mmHg; DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. Number of participants with at least one blood pressure exacerbation event is presented.
Outcome measures
| Measure |
Daprodustat
n=155 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=154 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Blood Pressure Exacerbation Event During Study
|
91 Participants
|
100 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected from participants for Hgb measurements. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Outcome measures
| Measure |
Daprodustat
n=139 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=141 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Post-randomization Hgb at Week 52
|
1.17 Grams per deciliter
Standard Error 0.117
|
1.13 Grams per deciliter
Standard Error 0.115
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 28 to 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as number of participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL.
Outcome measures
| Measure |
Daprodustat
n=133 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=133 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)
|
86 Participants
|
87 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 28 to 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'.
Outcome measures
| Measure |
Daprodustat
n=128 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=129 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis
|
57.0 Percentage of days
Interval 0.0 to 100.0
|
54.7 Percentage of days
Interval 0.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 28 to 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'.
Outcome measures
| Measure |
Daprodustat
n=128 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=129 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis
|
57.0 Percentage of days
Interval 0.0 to 100.0
|
54.7 Percentage of days
Interval 0.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population.
Number of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented.
Outcome measures
| Measure |
Daprodustat
n=157 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=155 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 8, 12, 28 and 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Outcome measures
| Measure |
Daprodustat
n=88 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=88 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52
Week 8, n=88,86
|
0.79 Scores on a scale
Standard Error 0.648
|
1.18 Scores on a scale
Standard Error 0.658
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52
Week 12, n=88,88
|
1.67 Scores on a scale
Standard Error 0.627
|
0.54 Scores on a scale
Standard Error 0.631
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52
Week 28, n=80,74
|
0.94 Scores on a scale
Standard Error 0.697
|
0.45 Scores on a scale
Standard Error 0.725
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52
Week 52, n=67,65
|
0.61 Scores on a scale
Standard Error 0.755
|
1.93 Scores on a scale
Standard Error 0.774
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 8, 12, 28 and 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Outcome measures
| Measure |
Daprodustat
n=88 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=88 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
Week 8, n=88,86
|
0.10 Scores on a scale
Standard Error 0.822
|
0.76 Scores on a scale
Standard Error 0.839
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
Week 12, n=88,88
|
0.08 Scores on a scale
Standard Error 0.813
|
1.60 Scores on a scale
Standard Error 0.824
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
Week 28, n=80,74
|
-0.02 Scores on a scale
Standard Error 0.905
|
0.30 Scores on a scale
Standard Error 0.942
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
Week 52, n=67,65
|
-0.95 Scores on a scale
Standard Error 1.029
|
-0.72 Scores on a scale
Standard Error 1.051
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 8, 12, 28 and 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain, general health, mental health, role-emotional (role limitations caused by emotional problems), role-physical (role limitations caused by physical problems), social functioning, physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Outcome measures
| Measure |
Daprodustat
n=88 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=88 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Bodily pain: Week 8, n=88,86
|
-0.41 Scores on a scale
Standard Error 0.833
|
-0.55 Scores on a scale
Standard Error 0.843
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Bodily pain: Week 12, n=88,88
|
-0.13 Scores on a scale
Standard Error 0.892
|
-0.06 Scores on a scale
Standard Error 0.895
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Bodily pain: Week 28, n=80,74
|
1.08 Scores on a scale
Standard Error 0.941
|
-1.26 Scores on a scale
Standard Error 0.976
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Bodily pain: Week 52, n=67,65
|
-2.00 Scores on a scale
Standard Error 1.084
|
0.61 Scores on a scale
Standard Error 1.109
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
General health: Week 8, n=88,86
|
0.80 Scores on a scale
Standard Error 0.662
|
0.75 Scores on a scale
Standard Error 0.674
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
General health: Week 12, n=88,88
|
0.87 Scores on a scale
Standard Error 0.651
|
0.59 Scores on a scale
Standard Error 0.658
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
General health: Week 28, n=80,74
|
0.63 Scores on a scale
Standard Error 0.693
|
0.37 Scores on a scale
Standard Error 0.720
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
General health: Week 52, n=67,65
|
0.40 Scores on a scale
Standard Error 0.823
|
0.58 Scores on a scale
Standard Error 0.841
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Mental health: Week 8, n=88,86
|
-0.90 Scores on a scale
Standard Error 0.825
|
0.25 Scores on a scale
Standard Error 0.841
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Mental health: Week 12, n=88,88
|
0.01 Scores on a scale
Standard Error 0.707
|
1.42 Scores on a scale
Standard Error 0.712
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Mental health: Week 28, n=80,74
|
-0.69 Scores on a scale
Standard Error 0.866
|
-0.21 Scores on a scale
Standard Error 0.902
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Mental health: Week 52, n=67,65
|
-0.53 Scores on a scale
Standard Error 0.994
|
-0.27 Scores on a scale
Standard Error 1.013
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Role-emotional: Week 8, n=88,86
|
0.83 Scores on a scale
Standard Error 0.880
|
0.50 Scores on a scale
Standard Error 0.896
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Role-emotional: Week 12, n=88,88
|
0.55 Scores on a scale
Standard Error 0.934
|
-0.07 Scores on a scale
Standard Error 0.946
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Role-emotional: Week 28, n=80,74
|
0.91 Scores on a scale
Standard Error 0.929
|
0.39 Scores on a scale
Standard Error 0.964
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Role-emotional: Week 52, n=67,65
|
-1.60 Scores on a scale
Standard Error 1.193
|
-0.11 Scores on a scale
Standard Error 1.216
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Role-physical: Week 8, n=88,86
|
1.34 Scores on a scale
Standard Error 0.806
|
2.64 Scores on a scale
Standard Error 0.818
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Role-physical: Week 12, n=88,88
|
2.39 Scores on a scale
Standard Error 0.712
|
1.69 Scores on a scale
Standard Error 0.716
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Role-physical: Week 28, n=80,74
|
0.62 Scores on a scale
Standard Error 0.799
|
1.49 Scores on a scale
Standard Error 0.829
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Role-physical: Week 52, n=67,65
|
1.49 Scores on a scale
Standard Error 0.895
|
2.22 Scores on a scale
Standard Error 0.913
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Social functioning: Week 8, n=88,86
|
0.52 Scores on a scale
Standard Error 0.929
|
1.55 Scores on a scale
Standard Error 0.947
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Social functioning: Week 12, n=88,88
|
0.98 Scores on a scale
Standard Error 0.774
|
2.15 Scores on a scale
Standard Error 0.783
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Social functioning: Week 28, n=80,74
|
1.03 Scores on a scale
Standard Error 0.943
|
0.95 Scores on a scale
Standard Error 0.980
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Social functioning: Week 52, n=67,65
|
0.39 Scores on a scale
Standard Error 1.085
|
-0.33 Scores on a scale
Standard Error 1.105
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 28 and 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Outcome measures
| Measure |
Daprodustat
n=80 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=74 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52
Week 28, n=80,74
|
-0.08 Scores on a scale
Standard Error 0.866
|
0.95 Scores on a scale
Standard Error 0.902
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52
Week 52, n=67,65
|
0.16 Scores on a scale
Standard Error 0.907
|
1.61 Scores on a scale
Standard Error 0.925
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 28 and 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Outcome measures
| Measure |
Daprodustat
n=80 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=74 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52
Week 28, n=80,74
|
0.55 Scores on a scale
Standard Error 0.863
|
0.83 Scores on a scale
Standard Error 0.898
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52
Week 52, n=67,65
|
0.14 Scores on a scale
Standard Error 0.947
|
1.58 Scores on a scale
Standard Error 0.973
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
EQ-5D-5L consists of 2 concepts-EQ-5D-5L descriptive system and EQ Visual Analogue Scale (EQ-VAS). EQ-5D-5L is self-assessment questionnaire, consisting of 5items covering 5 dimensions (mobility,self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale(no problems, slight problems, moderate problems, severe problems and extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state(e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health), higher the score better the health status. Change from Baseline was calculated as post-dose visit value-Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.
Outcome measures
| Measure |
Daprodustat
n=24 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=25 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52
|
0.00 Scores on a scale
Standard Error 0.041
|
-0.03 Scores on a scale
Standard Error 0.040
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
The EQ-5D-5L consists of 2 concepts -EQ-5D-5L descriptive system and EQ-VAS. The EQ-5D-5L is a self-assessment questionnaire, consisting of five items covering five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by a five-point Likert scale (no problems, slight problems, moderate problems, severe problems, and extreme problems). The range for the EQ-5D-5L index score is 0 to 1 with '0' is worst health and '1' is full health. The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst health one can imagine and 100 represents the best health one can imagine. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Outcome measures
| Measure |
Daprodustat
n=24 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=25 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in EQ Visual Analogue Scale (EQ-VAS) at Week 52
|
3.4 Scores on a scale
Standard Error 3.27
|
6.8 Scores on a scale
Standard Error 3.28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy/Weak scale consisting of 10 items; 2.Chest Pain/Shortness of Breath scale consisting of 4 items; and 3.Cognitive scale consisting of 3 items. The 4 CKD-AQ single items are: (shortness of breath, no activity), (severity-short breath, resting), (difficulty standing for long time) and (difficulty sleeping). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Outcome measures
| Measure |
Daprodustat
n=76 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=80 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52
Tired/Low energy/Weak domain
|
-2.36 Scores on a scale
Standard Error 2.007
|
4.07 Scores on a scale
Standard Error 1.990
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52
Chest pain/Shortness of breath domain
|
-1.83 Scores on a scale
Standard Error 1.593
|
2.28 Scores on a scale
Standard Error 1.557
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52
Cognitive domain
|
-4.17 Scores on a scale
Standard Error 1.893
|
2.43 Scores on a scale
Standard Error 1.852
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52
Shortness of breath, no activity
|
-1.90 Scores on a scale
Standard Error 1.861
|
1.14 Scores on a scale
Standard Error 1.826
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52
Severity-short breath, Resting
|
-4.16 Scores on a scale
Standard Error 1.869
|
0.12 Scores on a scale
Standard Error 1.836
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52
Difficulty standing for long time
|
-2.00 Scores on a scale
Standard Error 2.812
|
3.30 Scores on a scale
Standard Error 2.754
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52
Difficulty sleeping
|
-5.27 Scores on a scale
Standard Error 2.667
|
1.26 Scores on a scale
Standard Error 2.611
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 8, 12, 28 and 52Population: ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated worse outcome. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Outcome measures
| Measure |
Daprodustat
n=100 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=103 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S)
Week 8, n=100,100
|
0.16 Scores on a scale
Standard Error 0.091
|
-0.11 Scores on a scale
Standard Error 0.092
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S)
Week 12, n=100,103
|
0.02 Scores on a scale
Standard Error 0.077
|
-0.03 Scores on a scale
Standard Error 0.077
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S)
Week 28, n=92,85
|
0.09 Scores on a scale
Standard Error 0.086
|
-0.07 Scores on a scale
Standard Error 0.089
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S)
Week 52, n=75,77
|
0.22 Scores on a scale
Standard Error 0.106
|
0.04 Scores on a scale
Standard Error 0.105
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms.
Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic (PK) analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. Pharmacokinetic Population comprised of participants for whom a pharmacokinetic sample was obtained and analyzed.
Outcome measures
| Measure |
Daprodustat
n=19 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=26 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
n=20 Participants
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
n=18 Participants
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
n=1 Participants
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
n=1 Participants
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2531401: 3 hours, n=19,26,19,18,1,1,0,0,0
|
1.847 Nanogram per milliliter
Standard Deviation 1.7376
|
2.734 Nanogram per milliliter
Standard Deviation 2.6846
|
4.715 Nanogram per milliliter
Standard Deviation 7.2788
|
6.631 Nanogram per milliliter
Standard Deviation 7.1049
|
5.760 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
10.20 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
Daprodustat: Pre-Dose, n=19,26,20,18,1,1,0,0,0
|
2.118 Nanogram per milliliter
Standard Deviation 5.0030
|
1.015 Nanogram per milliliter
Standard Deviation 3.1451
|
0.5787 Nanogram per milliliter
Standard Deviation 1.5718
|
2.867 Nanogram per milliliter
Standard Deviation 6.6142
|
0.1030 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.1090 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
Daprodustat: 0.5 hour, n=19,26,20,18,0,1,0,0,0
|
5.675 Nanogram per milliliter
Standard Deviation 8.4998
|
4.664 Nanogram per milliliter
Standard Deviation 8.7508
|
10.27 Nanogram per milliliter
Standard Deviation 20.425
|
12.58 Nanogram per milliliter
Standard Deviation 23.742
|
—
|
145.0 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
Daprodustat: 1 hour, n=19,26,20,18,1,1,0,0,0
|
12.34 Nanogram per milliliter
Standard Deviation 13.435
|
21.45 Nanogram per milliliter
Standard Deviation 42.160
|
36.78 Nanogram per milliliter
Standard Deviation 62.497
|
45.48 Nanogram per milliliter
Standard Deviation 48.765
|
0.9120 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
79.60 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
Daprodustat: 2 hours, n=19,26,20,18,1,1,0,0,0
|
12.74 Nanogram per milliliter
Standard Deviation 9.9019
|
20.36 Nanogram per milliliter
Standard Deviation 22.210
|
54.68 Nanogram per milliliter
Standard Deviation 80.284
|
55.62 Nanogram per milliliter
Standard Deviation 51.471
|
32.00 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
27.60 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
Daprodustat: 3 hours, n=19,26,19,18,1,1,0,0,0
|
7.719 Nanogram per milliliter
Standard Deviation 5.9144
|
15.58 Nanogram per milliliter
Standard Deviation 13.694
|
43.34 Nanogram per milliliter
Standard Deviation 66.295
|
56.49 Nanogram per milliliter
Standard Deviation 74.357
|
25.30 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
11.00 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2391220: Pre-Dose, n=19,26,20,18,1,1,0,0,0
|
0.7106 Nanogram per milliliter
Standard Deviation 0.64028
|
2.124 Nanogram per milliliter
Standard Deviation 2.8721
|
2.087 Nanogram per milliliter
Standard Deviation 2.1371
|
3.560 Nanogram per milliliter
Standard Deviation 4.2255
|
4.450 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
6.560 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2391220: 0.5 hour, n=19,25,20,18,1,1,0,0,0
|
0.7602 Nanogram per milliliter
Standard Deviation 0.67950
|
1.807 Nanogram per milliliter
Standard Deviation 2.2007
|
1.822 Nanogram per milliliter
Standard Deviation 2.1355
|
2.410 Nanogram per milliliter
Standard Deviation 2.8243
|
3.950 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
6.740 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2391220: 1 hour, n=18,26,20,18,1,1,0,0,0
|
1.123 Nanogram per milliliter
Standard Deviation 0.76920
|
1.752 Nanogram per milliliter
Standard Deviation 1.8589
|
1.965 Nanogram per milliliter
Standard Deviation 2.2830
|
3.140 Nanogram per milliliter
Standard Deviation 2.4856
|
3.900 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
10.00 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2391220: 2 hours, n=19,26,20,18,1,1,0,0,0
|
1.745 Nanogram per milliliter
Standard Deviation 1.3160
|
2.969 Nanogram per milliliter
Standard Deviation 2.4659
|
4.008 Nanogram per milliliter
Standard Deviation 4.4522
|
6.336 Nanogram per milliliter
Standard Deviation 4.3723
|
4.700 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
16.20 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2391220: 3 hours, n=19,26,19,18,1,1,0,0,0
|
1.911 Nanogram per milliliter
Standard Deviation 1.2274
|
3.535 Nanogram per milliliter
Standard Deviation 2.7203
|
5.553 Nanogram per milliliter
Standard Deviation 6.5157
|
9.372 Nanogram per milliliter
Standard Deviation 6.6452
|
6.090 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
16.60 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2506104: Pre-Dose, n=19,26,20,18,1,1,0,0,0
|
1.270 Nanogram per milliliter
Standard Deviation 0.96071
|
3.508 Nanogram per milliliter
Standard Deviation 4.2066
|
3.879 Nanogram per milliliter
Standard Deviation 3.4207
|
5.921 Nanogram per milliliter
Standard Deviation 5.8981
|
8.710 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
9.500 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2506104: 0.5 hour, n=19,26,20,18,1,1,0,0,0
|
1.197 Nanogram per milliliter
Standard Deviation 0.85104
|
2.788 Nanogram per milliliter
Standard Deviation 2.9893
|
3.315 Nanogram per milliliter
Standard Deviation 3.4249
|
4.015 Nanogram per milliliter
Standard Deviation 3.7385
|
7.740 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
8.110 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2506104: 1 hour, n=19,26,20,18,1,1,0,0,0
|
1.364 Nanogram per milliliter
Standard Deviation 0.96292
|
2.610 Nanogram per milliliter
Standard Deviation 2.4761
|
3.268 Nanogram per milliliter
Standard Deviation 3.4808
|
4.333 Nanogram per milliliter
Standard Deviation 3.0505
|
7.460 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
12.40 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2506104: 2 hours, n=19,26,20,18,1,1,0,0,0
|
1.966 Nanogram per milliliter
Standard Deviation 1.3440
|
3.583 Nanogram per milliliter
Standard Deviation 2.8427
|
4.989 Nanogram per milliliter
Standard Deviation 5.2109
|
7.130 Nanogram per milliliter
Standard Deviation 4.5105
|
8.930 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
19.60 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2506104: 3 hours, n=19,26,19,18,1,1,0,0,0
|
2.190 Nanogram per milliliter
Standard Deviation 1.3898
|
4.145 Nanogram per milliliter
Standard Deviation 3.1757
|
6.503 Nanogram per milliliter
Standard Deviation 7.5130
|
9.942 Nanogram per milliliter
Standard Deviation 7.0616
|
10.10 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
22.00 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2531401: Pre-Dose, n=19,26,20,18,1,1,0,0,0
|
1.642 Nanogram per milliliter
Standard Deviation 1.4836
|
2.729 Nanogram per milliliter
Standard Deviation 1.8934
|
3.750 Nanogram per milliliter
Standard Deviation 3.8006
|
5.111 Nanogram per milliliter
Standard Deviation 4.0632
|
5.660 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
7.760 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2531401: 0.5 hour, n=19,26,20,18,1,1,0,0,0
|
1.427 Nanogram per milliliter
Standard Deviation 1.2870
|
2.170 Nanogram per milliliter
Standard Deviation 1.6621
|
3.263 Nanogram per milliliter
Standard Deviation 3.8737
|
3.800 Nanogram per milliliter
Standard Deviation 2.8722
|
4.960 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
6.460 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2531401: 1 hour, n=19,26,20,18,1,1,0,0,0
|
1.399 Nanogram per milliliter
Standard Deviation 1.4595
|
1.979 Nanogram per milliliter
Standard Deviation 1.6316
|
3.146 Nanogram per milliliter
Standard Deviation 4.0334
|
3.776 Nanogram per milliliter
Standard Deviation 3.4411
|
4.810 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
6.630 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2531401: 2 hours, n=19,26,20,18,1,1,0,0,0
|
1.690 Nanogram per milliliter
Standard Deviation 1.6309
|
2.338 Nanogram per milliliter
Standard Deviation 2.1467
|
3.711 Nanogram per milliliter
Standard Deviation 5.0223
|
4.892 Nanogram per milliliter
Standard Deviation 4.7877
|
5.190 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
8.290 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed. Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms.
Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12.
Outcome measures
| Measure |
Daprodustat
n=19 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=26 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
n=20 Participants
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
n=18 Participants
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
n=1 Participants
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
n=1 Participants
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
Daprodustat
|
2.118 Nanogram per milliliter
Standard Deviation 5.0030
|
1.015 Nanogram per milliliter
Standard Deviation 3.1451
|
0.5787 Nanogram per milliliter
Standard Deviation 1.5718
|
2.867 Nanogram per milliliter
Standard Deviation 6.6142
|
0.1030 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.1090 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2391220
|
0.7106 Nanogram per milliliter
Standard Deviation 0.64028
|
2.124 Nanogram per milliliter
Standard Deviation 2.8721
|
2.087 Nanogram per milliliter
Standard Deviation 2.1371
|
3.560 Nanogram per milliliter
Standard Deviation 4.2255
|
4.450 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
6.560 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2506104
|
1.270 Nanogram per milliliter
Standard Deviation 0.96071
|
3.508 Nanogram per milliliter
Standard Deviation 4.2066
|
3.879 Nanogram per milliliter
Standard Deviation 3.4207
|
5.921 Nanogram per milliliter
Standard Deviation 5.8981
|
8.710 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
9.500 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2531401
|
1.642 Nanogram per milliliter
Standard Deviation 1.4836
|
2.729 Nanogram per milliliter
Standard Deviation 1.8934
|
3.750 Nanogram per milliliter
Standard Deviation 3.8006
|
5.111 Nanogram per milliliter
Standard Deviation 4.0632
|
5.660 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
7.760 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed. Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms.
Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12.
Outcome measures
| Measure |
Daprodustat
n=19 Participants
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=26 Participants
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
Daprodustat 4 mg
n=20 Participants
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
|
Daprodustat 6 mg
n=18 Participants
Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.
|
Daprodustat 8 mg
n=1 Participants
Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.
|
Daprodustat 10 mg
n=1 Participants
Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.
|
Daprodustat 12 mg
Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.
|
Daprodustat 16 mg
Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.
|
Daprodustat 24 mg
Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2391220
|
2.160 Nanogram per milliliter
Standard Deviation 1.2596
|
4.139 Nanogram per milliliter
Standard Deviation 3.3561
|
5.780 Nanogram per milliliter
Standard Deviation 6.2840
|
10.36 Nanogram per milliliter
Standard Deviation 6.3377
|
6.090 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
16.60 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
Daprodustat
|
21.74 Nanogram per milliliter
Standard Deviation 10.998
|
32.29 Nanogram per milliliter
Standard Deviation 40.166
|
76.92 Nanogram per milliliter
Standard Deviation 81.867
|
100.2 Nanogram per milliliter
Standard Deviation 74.086
|
32.00 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
145.0 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2506104
|
2.477 Nanogram per milliliter
Standard Deviation 1.3625
|
5.212 Nanogram per milliliter
Standard Deviation 4.5562
|
7.075 Nanogram per milliliter
Standard Deviation 7.1313
|
11.60 Nanogram per milliliter
Standard Deviation 6.8731
|
10.10 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
22.00 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
GSK2531401
|
2.283 Nanogram per milliliter
Standard Deviation 1.8210
|
3.565 Nanogram per milliliter
Standard Deviation 2.6091
|
5.328 Nanogram per milliliter
Standard Deviation 6.9034
|
7.836 Nanogram per milliliter
Standard Deviation 6.6199
|
5.760 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
10.20 Nanogram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
Adverse Events
Daprodustat
Serious events: 52 serious events
Other events: 76 other events
Deaths: 17 deaths
Darbepoetin Alfa
Serious events: 51 serious events
Other events: 74 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Daprodustat
n=157 participants at risk
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=155 participants at risk
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
2.5%
4/157 • Number of events 7 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
4.5%
7/155 • Number of events 7 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Peritonitis
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.9%
3/155 • Number of events 5 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Septic shock
|
1.3%
2/157 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.3%
2/155 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Post procedural infection
|
1.9%
3/157 • Number of events 3 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.9%
3/155 • Number of events 3 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Localised infection
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Staphylococcal infection
|
1.3%
2/157 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Urosepsis
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Bronchiolitis
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
COVID-19
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Clostridial sepsis
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Device related bacteraemia
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Escherichia infection
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Infected skin ulcer
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Leptospirosis
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Streptococcal infection
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.2%
5/157 • Number of events 9 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.9%
3/155 • Number of events 8 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.3%
2/157 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.3%
2/155 • Number of events 4 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.9%
3/155 • Number of events 3 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.9%
3/155 • Number of events 3 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.3%
2/155 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.3%
2/155 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.3%
2/157 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Bradycardia
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
2.6%
4/155 • Number of events 5 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.3%
2/155 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.64%
1/157 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Inadequate haemodialysis
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Open globe injury
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Peritoneal dialysate leakage
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Peritoneal dialysis complication
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Vascular access malfunction
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.64%
1/157 • Number of events 7 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.3%
2/155 • Number of events 3 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.3%
2/155 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.9%
3/155 • Number of events 3 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Volvulus
|
0.64%
1/157 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Bloody peritoneal effluent
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Diabetic gastropathy
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Nervous system disorders
Syncope
|
0.64%
1/157 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.3%
2/155 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Vascular disorders
Hypertension
|
1.3%
2/157 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Vascular disorders
Hypertensive urgency
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Vascular disorders
Lymphocele
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Vascular disorders
Steal syndrome
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.3%
2/155 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
General disorders
Pyrexia
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
General disorders
Sudden death
|
1.3%
2/157 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
General disorders
Catheter site haemorrhage
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
General disorders
Generalised oedema
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Product Issues
Device malfunction
|
2.5%
4/157 • Number of events 4 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Product Issues
Device dislocation
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
1.3%
2/155 • Number of events 2 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Renal and urinary disorders
Azotaemia
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer stage I
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Eye disorders
Retinopathy hypertensive
|
0.64%
1/157 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.00%
0/155 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/157 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
0.65%
1/155 • Number of events 1 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
Other adverse events
| Measure |
Daprodustat
n=157 participants at risk
Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \[g/dL\]).
|
Darbepoetin Alfa
n=155 participants at risk
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
|---|---|---|
|
Vascular disorders
Hypertension
|
17.2%
27/157 • Number of events 51 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
15.5%
24/155 • Number of events 35 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Vascular disorders
Dialysis hypotension
|
13.4%
21/157 • Number of events 34 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
9.7%
15/155 • Number of events 22 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Vascular disorders
Hypotension
|
4.5%
7/157 • Number of events 8 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
5.8%
9/155 • Number of events 9 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.9%
14/157 • Number of events 17 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
6.5%
10/155 • Number of events 10 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
11/157 • Number of events 16 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
3.2%
5/155 • Number of events 5 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
8/157 • Number of events 13 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
3.9%
6/155 • Number of events 6 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
7/157 • Number of events 12 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
5.8%
9/155 • Number of events 9 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
7/157 • Number of events 9 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
7.1%
11/155 • Number of events 12 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Infections and infestations
Catheter site infection
|
3.2%
5/157 • Number of events 5 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
5.2%
8/155 • Number of events 11 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.5%
7/157 • Number of events 12 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
5.8%
9/155 • Number of events 12 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Nervous system disorders
Headache
|
7.6%
12/157 • Number of events 14 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
5.8%
9/155 • Number of events 10 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
2.5%
4/157 • Number of events 4 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
5.2%
8/155 • Number of events 13 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
|
Metabolism and nutrition disorders
Fluid overload
|
5.7%
9/157 • Number of events 9 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
3.9%
6/155 • Number of events 7 • All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER