Trial Outcomes & Findings for Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF) (NCT NCT03446612)
NCT ID: NCT03446612
Last Updated: 2024-03-27
Results Overview
Venous occlusion plethysmography was used for FBF assessment. Acetylcholine (ACH) was infused intra-arterially at 7.5, 15 and 30 micrograms/minute (ug/min) each for 6 minutes per infusion. FBF ratio was defined as the ratio of a participant's treatment (infused) arm value divided by the non-treatment (non-infused) arm value. The overall ratio was determined by taking the participant's Day 42 FBF ratio and dividing by the Day 1 FBF ratio.
TERMINATED
PHASE2
6 participants
Day 1 to Day 42
2024-03-27
Participant Flow
This was an open label, parallel group study that evaluated the effect of daprodustat and darbepoetin alfa on forearm blood flow (FBF) in participants with anemia of chronic kidney disease that are not dialysis dependent.
Participants were enrolled in multiple centers in United Kingdom. A total of 6 participants were enrolled in the study and only 5 participants were randomized to receive study treatment.
Participant milestones
| Measure |
Daprodustat
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Daprodustat
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Overall Study
Protocol defined stopping criteria
|
0
|
1
|
Baseline Characteristics
Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)
Baseline characteristics by cohort
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 Years
STANDARD_DEVIATION 2.83 • n=5 Participants
|
53.0 Years
STANDARD_DEVIATION 15.72 • n=7 Participants
|
56.6 Years
STANDARD_DEVIATION 12.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European Heritage
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 42Population: Pharmacodynamic Per-Protocol (PDPP) population included all randomized participants who provided pharmacodynamic (PD) data at Day 1 and Day 42. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Venous occlusion plethysmography was used for FBF assessment. Acetylcholine (ACH) was infused intra-arterially at 7.5, 15 and 30 micrograms/minute (ug/min) each for 6 minutes per infusion. FBF ratio was defined as the ratio of a participant's treatment (infused) arm value divided by the non-treatment (non-infused) arm value. The overall ratio was determined by taking the participant's Day 42 FBF ratio and dividing by the Day 1 FBF ratio.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=2 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42)
ACH 7.5 ug/min, n=2, 2
|
1.1304 Ratio
Standard Deviation 0.30030
|
0.4351 Ratio
Standard Deviation 0.17032
|
|
Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42)
ACH 15 ug/min, n=1, 2
|
0.7866 Ratio
Standard Deviation NA
Not applicable (NA) indicates standard deviation could not be calculated as a single participant was analyzed.
|
0.6183 Ratio
Standard Deviation 0.00435
|
|
Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42)
ACH 30 ug/min, n=1, 2
|
1.1328 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
0.8090 Ratio
Standard Deviation 0.28395
|
SECONDARY outcome
Timeframe: Day 1 to Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Venous occlusion plethysmography was used for FBF assessment. Acetylcholine was infused intra-arterially at 7.5, 15 and 30 ug/min each for 6 minutes per infusion. Measures were made in both arms concurrently. Change in the absolute FBF from Day 1 to Day 42 in response to acetylcholine is the difference between absolute value of FBF in infused arm on Day 1 and Day 42 in response to acetylcholine.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=2 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in the Absolute FBF From Day 1 to Day 42 in Response to Acetylcholine
7.5 ug/min, n=2, 2
|
8.3180 ug/min
Standard Deviation 4.50592
|
-6.0360 ug/min
Standard Deviation 3.09976
|
|
Change in the Absolute FBF From Day 1 to Day 42 in Response to Acetylcholine
15 ug/min, n=1, 2
|
-4.6374 ug/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
-8.8299 ug/min
Standard Deviation 9.98143
|
|
Change in the Absolute FBF From Day 1 to Day 42 in Response to Acetylcholine
30 ug/min, n=1, 2
|
-2.6735 ug/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
-4.5121 ug/min
Standard Deviation 5.66731
|
SECONDARY outcome
Timeframe: Day 1 to Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed.
Venous occlusion plethysmography was used for FBF assessment. Sodium nitroprusside was infused at 3 and 10 ug/min each for 6 minutes per infusion into the brachial artery of the test arm. FBF ratio was defined as the ratio of a participant's treatment (infused) arm value divided by the non-treatment (non-infused) arm value. The overall ratio was determined by taking the participant's Day 42 FBF ratio and dividing by the Day 1 FBF ratio.
Outcome measures
| Measure |
Daprodustat
n=1 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=2 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in FBF Ratio in Response to Sodium Nitroprusside (Day 1 to Day 42)
3 ug/min
|
1.0388 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
0.7420 Ratio
Standard Deviation 0.07407
|
|
Change in FBF Ratio in Response to Sodium Nitroprusside (Day 1 to Day 42)
10 ug/min
|
2.1447 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
0.7022 Ratio
Standard Deviation 0.00860
|
SECONDARY outcome
Timeframe: Day 1 to Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed.
Venous occlusion plethysmography was used for FBF assessment. Sodium nitroprusside was infused at 3 and 10 ug/min each for 6 minutes per infusion into the brachial artery of the test arm. Measures were made in both arms concurrently. Change in the absolute FBF from Day 1 to Day 42 in response to sodium nitroprusside is the difference between absolute value of FBF in infused arm on Day 1 and Day 42 in response to sodium nitroprusside.
Outcome measures
| Measure |
Daprodustat
n=1 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=2 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in the Absolute FBF From Day 1 to Day 42 in Response to Sodium Nitroprusside
3 ug/min
|
-0.2560 ug/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
0.3844 ug/min
Standard Deviation 0.52197
|
|
Change in the Absolute FBF From Day 1 to Day 42 in Response to Sodium Nitroprusside
10 ug/min
|
6.8103 ug/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
-0.2873 ug/min
Standard Deviation 1.11519
|
SECONDARY outcome
Timeframe: Day 1 to Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed.
Venous occlusion plethysmography was used for FBF assessment. Effects on basal nitric oxide synthesis was assessed using L-NMMA at doses of 2 and 8 micromoles per minute (umol/min) each infused for 6 minutes into the brachial artery of the test arm. FBF ratio was defined as the ratio of a participant's treatment (infused) arm value divided by the non-treatment (non-infused) arm value. The overall ratio was determined by taking the participant's Day 42 FBF ratio and dividing by the Day 1 FBF ratio.
Outcome measures
| Measure |
Daprodustat
n=1 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=1 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in FBF Ratio in Response to NG-monomethyl Arginine Acetate (L-NMMA) (Day 1 to Day 42)
2 umol/min
|
0.7426 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
0.9024 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change in FBF Ratio in Response to NG-monomethyl Arginine Acetate (L-NMMA) (Day 1 to Day 42)
8 umol/min
|
0.4975 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
0.8690 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
SECONDARY outcome
Timeframe: Day 1 to Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed.
Venous occlusion plethysmography was used for FBF assessment. Effects on basal nitric oxide synthesis was assessed using L-NMMA at doses of 2 and 8 umol/min each infused for 6 minutes into the brachial artery of the test arm. Measures were made in both arms concurrently. Change in the absolute FBF from Day 1 to Day 42 in response to L-NMMA is the difference between absolute value of FBF in infused arm on Day 1 and Day 42 in response to L-NMMA.
Outcome measures
| Measure |
Daprodustat
n=1 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=1 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in the Absolute FBF From Day 1 to Day 42 in Response to L-NMMA
2 umol/min
|
1.1508 umol/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
0.3558 umol/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change in the Absolute FBF From Day 1 to Day 42 in Response to L-NMMA
8 umol/min
|
0.0974 umol/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
0.0399 umol/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
SECONDARY outcome
Timeframe: Day 1 and Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Venous occlusion plethysmography was used for FBF assessment. Acetylcholine was infused intra-arterially at 7.5, 15 and 30 ug/min each for 6 minutes per infusion. The Day 42 ratio was calculated by taking the participants Day 42 treatment (infused) arm and dividing by the Day 42 non-treatment (control) arm value. The Day 1 ratio was calculated by taking the participants Day 1 treatment (infused) arm and dividing by the Day 1 non-treatment (control) arm value. Change in FBF ratio from Day 1 to Day 42 was determined by taking the participants Day 42 ratio and dividing by the Day 1 ratio.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in FBF Ratio in Response to Acetylcholine at Day 42 Versus (vs) Day 1 in Participants Treated With Daprodustat
7.5 ug/min, n=2
|
0.2744 Ratio
Standard Deviation 0.91996
|
—
|
|
Change in FBF Ratio in Response to Acetylcholine at Day 42 Versus (vs) Day 1 in Participants Treated With Daprodustat
15 ug/min, n=1
|
-0.8503 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed
|
—
|
|
Change in FBF Ratio in Response to Acetylcholine at Day 42 Versus (vs) Day 1 in Participants Treated With Daprodustat
30 ug/min, n=1
|
0.5482 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed.
Venous occlusion plethysmography was used for FBF assessment. Sodium nitroprusside was infused at 3 and 10 ug/min each for 6 minutes per infusion into the brachial artery of the test arm. The Day 42 ratio was calculated by taking the participants Day 42 treatment (infused) arm and dividing by the Day 42 non-treatment (control) arm value. The Day 1 ratio was calculated by taking the participants Day 1 treatment (infused) arm and dividing by the Day 1 non-treatment (control) arm value. Change in FBF ratio from Day 1 to Day 42 was determined by taking the participants Day 42 ratio and dividing by the Day 1 ratio.
Outcome measures
| Measure |
Daprodustat
n=1 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in FBF Ratio in Response to Sodium Nitroprusside at Day 42 vs Day 1 in Participants Treated With Daprodustat
3 ug/min
|
0.1618 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change in FBF Ratio in Response to Sodium Nitroprusside at Day 42 vs Day 1 in Participants Treated With Daprodustat
10 ug/min
|
3.2651 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed.
Venous occlusion plethysmography was used for FBF assessment. Effects on basal nitric oxide synthesis was assessed using L-NMMA at doses of 2 and 8 umol/min each infused for 6 minutes into the brachial artery of the test arm. The Day 42 ratio was calculated by taking the participants Day 42 treatment (infused) arm and dividing by the Day 42 non-treatment (control) arm value. The Day 1 ratio was calculated by taking the participants Day 1 treatment (infused) arm and dividing by the Day 1 non-treatment (control) arm value. Change in FBF ratio from Day 1 to Day 42 was determined by taking the participants Day 42 ratio and dividing by the Day 1 ratio.
Outcome measures
| Measure |
Daprodustat
n=1 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in FBF Ratio in Response to L-NMMA at Day 42 vs Day 1 in Participants Treated With Daprodustat
2 umol/min
|
-0.3896 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change in FBF Ratio in Response to L-NMMA at Day 42 vs Day 1 in Participants Treated With Daprodustat
8 umol/min
|
-0.7216 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 42Population: PDPP Population
Venous occlusion plethysmography was used for FBF assessment. Acetylcholine was infused intra-arterially at 7.5, 15 and 30 ug/min each for 6 minutes per infusion. The Day 42 ratio was calculated by taking the participants Day 42 treatment (infused) arm and dividing by the Day 42 non-treatment (control) arm value. The Day 1 ratio was calculated by taking the participants Day 1 treatment (infused) arm and dividing by the Day 1 non-treatment (control) arm value. Change in FBF ratio from Day 1 to Day 42 was determined by taking the participants Day 42 ratio and dividing by the Day 1 ratio.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in FBF Ratio in Response to Acetylcholine at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
7.5 ug/min
|
-2.0376 Ratio
Standard Deviation 0.63291
|
—
|
|
Change in FBF Ratio in Response to Acetylcholine at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
15 ug/min
|
-1.4559 Ratio
Standard Deviation 0.01558
|
—
|
|
Change in FBF Ratio in Response to Acetylcholine at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
30 ug/min
|
-1.0652 Ratio
Standard Deviation 1.56389
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 42Population: PDPP Population.
Venous occlusion plethysmography was used for FBF assessment. Sodium nitroprusside was infused at 3 and 10 ug/min each for 6 minutes per infusion into the brachial artery of the test arm. The Day 42 ratio was calculated by taking the participants Day 42 treatment (infused) arm and dividing by the Day 42 non-treatment (control) arm value. The Day 1 ratio was calculated by taking the participants Day 1 treatment (infused) arm and dividing by the Day 1 non-treatment (control) arm value. Change in FBF ratio from Day 1 to Day 42 was determined by taking the participants Day 42 ratio and dividing by the Day 1 ratio.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in FBF Ratio in Response to Sodium Nitroprusside at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
3 ug/min
|
-0.7503 Ratio
Standard Deviation 0.26692
|
—
|
|
Change in FBF Ratio in Response to Sodium Nitroprusside at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
10 ug/min
|
-1.2405 Ratio
Standard Deviation 0.15366
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed.
Venous occlusion plethysmography was used for FBF assessment. Effects on basal nitric oxide synthesis was assessed using L-NMMA at doses of 2 and 8 umol/min each infused for 6 minutes into the brachial artery of the test arm. The Day 42 ratio was calculated by taking the participants Day 42 treatment (infused) arm and dividing by the Day 42 non-treatment (control) arm value. The Day 1 ratio was calculated by taking the participants Day 1 treatment (infused) arm and dividing by the Day 1 non-treatment (control) arm value. Change in FBF ratio from Day 1 to Day 42 was determined by taking the participants Day 42 ratio and dividing by the Day 1 ratio.
Outcome measures
| Measure |
Daprodustat
n=1 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in FBF Ratio in Response to L-NMMA at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
2 umol/min
|
-0.081 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change in FBF Ratio in Response to L-NMMA at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
8 umol/min
|
-0.1351 Ratio
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Venous occlusion plethysmography was used for FBF assessment. Acetylcholine was infused intra-arterially at 7.5, 15 and 30 ug/min each for 6 minutes per infusion. Measures were made in both arms concurrently. Change in the absolute FBF in response to acetylcholine at Day 42 vs Day1 is the difference between absolute value of FBF in infused arm on Day 1 and Day 42 in response to acetylcholine in participants treated with daprodustat.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in the Absolute FBF in Response to Acetylcholine at Day 42 vs Day 1 in Participants Treated With Daprodustat
7.5 ug/min, n=2
|
8.3180 ug/min
Standard Deviation 4.50592
|
—
|
|
Change in the Absolute FBF in Response to Acetylcholine at Day 42 vs Day 1 in Participants Treated With Daprodustat
15 ug/min, n=1
|
-4.6374 ug/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change in the Absolute FBF in Response to Acetylcholine at Day 42 vs Day 1 in Participants Treated With Daprodustat
30 ug/min, n=1
|
-2.6735 ug/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed.
Venous occlusion plethysmography was used for FBF assessment. Sodium nitroprusside was infused at 3 and 10 ug/min each for 6 minutes per infusion into the brachial artery of the test arm. Measures were made in both arms concurrently. Change in the absolute FBF in response to sodium nitroprusside at Day 42 vs Day 1 is the difference between absolute value of FBF in infused arm on Day 1 and Day 42 in response to sodium nitroprusside in participants treated with daprodustat.
Outcome measures
| Measure |
Daprodustat
n=1 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in the Absolute FBF in Response to Sodium Nitroprusside at Day 42 vs Day 1 in Participants Treated With Daprodustat
3 ug/min
|
-0.2560 ug/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change in the Absolute FBF in Response to Sodium Nitroprusside at Day 42 vs Day 1 in Participants Treated With Daprodustat
10 ug/min
|
6.8103 ug/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed.
Venous occlusion plethysmography was used for FBF assessment. Effects on basal nitric oxide synthesis was assessed using L-NMMA at doses of 2 and 8 umol/min each infused for 6 minutes into the brachial artery of the test arm. Measures were made in both arms concurrently. Change in the absolute FBF in response to L-NMMA at Day 42 vs Day 1 is the difference between absolute value of FBF in infused arm on Day 1 and Day 42 in response to L-NMMA in participants treated with daprodustat.
Outcome measures
| Measure |
Daprodustat
n=1 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in the Absolute FBF in Response to L-NMMA at Day 42 vs Day 1 in Participants Treated With Daprodustat
2 umol/min
|
1.1508 umol/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change in the Absolute FBF in Response to L-NMMA at Day 42 vs Day 1 in Participants Treated With Daprodustat
8 umol/min
|
0.0974 umol/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 42Population: PDPP Population
Venous occlusion plethysmography was used for FBF assessment. Acetylcholine was infused intra-arterially at 7.5, 15 and 30 ug/min each for 6 minutes per infusion. Measures were made in both arms concurrently. Change in the absolute FBF in response to acetylcholine at Day 42 vs Day1 is the difference between absolute value of FBF in infused arm on Day 1 and Day 42 in response to acetylcholine in participants treated with darbepoetin alfa.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in the Absolute FBF in Response to Acetylcholine at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
7.5 ug/min
|
-6.0360 ug/min
Standard Deviation 3.09976
|
—
|
|
Change in the Absolute FBF in Response to Acetylcholine at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
15 ug/min
|
-8.8299 ug/min
Standard Deviation 9.98143
|
—
|
|
Change in the Absolute FBF in Response to Acetylcholine at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
30 ug/min
|
-4.5121 ug/min
Standard Deviation 5.66731
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 42Population: PDPP Population
Venous occlusion plethysmography was used for FBF assessment. Sodium nitroprusside was infused at 3 and 10 ug/min each for 6 minutes per infusion into the brachial artery of the test arm. Measures were made in both arms concurrently. Change in the absolute FBF in response to sodium nitroprusside at Day 42 vs Day 1 is the difference between absolute value of FBF in infused arm on Day 1 and Day 42 in response to sodium nitroprusside in participants treated with darbepoetin alfa.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in the Absolute FBF in Response to Sodium Nitroprusside at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
3 ug/min
|
0.3844 ug/min
Standard Deviation 0.52197
|
—
|
|
Change in the Absolute FBF in Response to Sodium Nitroprusside at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
10 ug/min
|
-0.2873 ug/min
Standard Deviation 1.11519
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 42Population: PDPP Population. Only those participants with data available at the specified data points were analyzed.
Venous occlusion plethysmography was used for FBF assessment. Effects on basal nitric oxide synthesis was assessed using L-NMMA at doses of 2 and 8 umol/min each infused for 6 minutes into the brachial artery of the test arm. Measures were made in both arms concurrently. Change in the absolute FBF in response to L-NMMA at Day 42 vs Day 1 is the difference between absolute value of FBF in infused arm on Day 1 and Day 42 in response to L-NMMA in participants treated with darbepoetin alfa.
Outcome measures
| Measure |
Daprodustat
n=1 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in the Absolute FBF in Response to L-NMMA at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
2 umol/min
|
0.3558 umol/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change in the Absolute FBF in Response to L-NMMA at Day 42 vs Day 1 in Participants Treated With Darbepoetin Alfa
8 umol/min
|
0.0399 umol/min
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 42Population: PDPP Population
Pulse wave analysis (PWA) is a reproducible, noninvasive method for assessing AIx (a measure of the contribution that wave reflection makes to the arterial pressure waveform). The amplitude and timing of the reflected wave ultimately depends on the stiffness of the small (pre-resistance) vessels and large arteries, and thus, AIx provides a measure of systemic arterial stiffness. A high-fidelity micro manometer was used to obtain accurate readings of the peripheral pressure waveforms by flattening, but not occluding, the radial artery of the dominant arm using gentle pressure. AIx was defined as the augmentation (difference between systolic peaks) expressed as a percentage of the overall pulse pressure. Data for change in AIx from Day 1 to 42 was presented.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=2 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in Augmentation Index (AIx) From Day 1 to 42
|
-3.000 Percentage
Standard Deviation 0.0000
|
-4.000 Percentage
Standard Deviation 2.8284
|
SECONDARY outcome
Timeframe: Day 1 to Day 42Population: PDPP Population
PWV was assessed with a high-fidelity micro manometer which was used to obtain accurate readings of the peripheral pressure waveforms by flattening, but not occluding, the carotid and femoral arteries as the two points of measure. Data for change in PWV from Day 1 to 42 was presented.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=2 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change in Pulse Wave Velocity (PWV) From Day 1 to Day 42
|
2.075 meters per second (m/sec)
Standard Deviation 1.4496
|
0.100 meters per second (m/sec)
Standard Deviation 0.2828
|
SECONDARY outcome
Timeframe: Up to 59 daysPopulation: Safety Population includes all randomised participants who received at least one dose of study treatment.
An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth effect.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 59 daysPopulation: Safety Population
AESIs were identified based on non-clinical studies with daprodustat, clinical experience with recombinant human erythropoietins (rhEPOs), and current information regarding hypoxia-inducible factor (HIF)-regulated pathways in mediating hypoxia-associated pathophysiology. The AESIs for daprodustat were identified as follows: Thrombosis and/or tissue ischemia secondary to excessive erythropoiesis; Death, MI, stroke, heart failure, thromboembolic events, thrombosis of vascular access; Cardiomyopathy; Pulmonary artery hypertension; Cancer-related mortality and tumor progression and recurrence Esophageal and gastric erosions; Proliferative retinopathy, macular edema, choroidal neovascularization; Exacerbation of rheumatoid arthritis and Worsening of hypertension.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Number of Participants With Any AE of Special Interest (AESI)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 42Population: Safety Population
Number of participants who discontinued the randomized study treatment were assessed.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Number of Participants Discontinuing the Randomized Study Treatment
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 14, 28, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
DBP and SBP were measured in a semi-supine position with a completely automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 28, n=2, 3
|
135.5 millimeters of mercury (mmHg)
Standard Deviation 12.02
|
147.3 millimeters of mercury (mmHg)
Standard Deviation 39.63
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 1, n=2, 3
|
73.5 millimeters of mercury (mmHg)
Standard Deviation 13.44
|
69.3 millimeters of mercury (mmHg)
Standard Deviation 13.05
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 14, n=2, 3
|
67.0 millimeters of mercury (mmHg)
Standard Deviation 5.66
|
74.3 millimeters of mercury (mmHg)
Standard Deviation 13.05
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 28, n=2, 3
|
73.5 millimeters of mercury (mmHg)
Standard Deviation 7.78
|
79.3 millimeters of mercury (mmHg)
Standard Deviation 25.54
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 42, n=2, 2
|
76.0 millimeters of mercury (mmHg)
Standard Deviation 9.90
|
73.0 millimeters of mercury (mmHg)
Standard Deviation 8.49
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 59, n=2, 3
|
69.5 millimeters of mercury (mmHg)
Standard Deviation 9.19
|
82.7 millimeters of mercury (mmHg)
Standard Deviation 18.15
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 1, n=2, 3
|
144.0 millimeters of mercury (mmHg)
Standard Deviation 43.84
|
134.3 millimeters of mercury (mmHg)
Standard Deviation 18.34
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 14, n=2, 3
|
130.0 millimeters of mercury (mmHg)
Standard Deviation 28.28
|
127.7 millimeters of mercury (mmHg)
Standard Deviation 23.25
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 42, n=2, 2
|
145.5 millimeters of mercury (mmHg)
Standard Deviation 33.23
|
148.0 millimeters of mercury (mmHg)
Standard Deviation 45.25
|
|
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 59, n=2, 3
|
135.5 millimeters of mercury (mmHg)
Standard Deviation 31.82
|
142.3 millimeters of mercury (mmHg)
Standard Deviation 29.14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 14, 28, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
DBP and SBP were measured in a semi-supine position with a completely automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in DBP and SBP
DBP, Day 14, n=2, 3
|
-6.5 mmHg
Standard Deviation 7.78
|
5.0 mmHg
Standard Deviation 0.00
|
|
Change From Baseline in DBP and SBP
DBP, Day 28, n=2, 3
|
0.0 mmHg
Standard Deviation 21.21
|
10.0 mmHg
Standard Deviation 13.00
|
|
Change From Baseline in DBP and SBP
DBP, Day 42, n=2, 2
|
2.5 mmHg
Standard Deviation 3.54
|
10.5 mmHg
Standard Deviation 0.71
|
|
Change From Baseline in DBP and SBP
DBP, Day 59, n=2, 3
|
-4.0 mmHg
Standard Deviation 4.24
|
13.3 mmHg
Standard Deviation 5.13
|
|
Change From Baseline in DBP and SBP
SBP, Day 14, n=2, 3
|
-14.0 mmHg
Standard Deviation 15.56
|
-6.7 mmHg
Standard Deviation 4.93
|
|
Change From Baseline in DBP and SBP
SBP, Day 28, n=2, 3
|
-8.5 mmHg
Standard Deviation 31.82
|
13.0 mmHg
Standard Deviation 38.43
|
|
Change From Baseline in DBP and SBP
SBP, Day 42, n=2, 2
|
1.5 mmHg
Standard Deviation 10.61
|
10.5 mmHg
Standard Deviation 20.51
|
|
Change From Baseline in DBP and SBP
SBP, Day 59, n=2, 3
|
-8.5 mmHg
Standard Deviation 12.02
|
8.0 mmHg
Standard Deviation 24.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Full 12-lead ECG were recorded with the participant in a semi-supine position to measure heart rate.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of Electrocardiogram (ECG) Mean Heart Rate
Day 1, n=2, 3
|
69.0 Beats per minute
Standard Deviation 2.83
|
70.0 Beats per minute
Standard Deviation 14.11
|
|
Absolute Values of Electrocardiogram (ECG) Mean Heart Rate
Day 42, n=2, 2
|
61.0 Beats per minute
Standard Deviation 14.14
|
62.0 Beats per minute
Standard Deviation 9.90
|
|
Absolute Values of Electrocardiogram (ECG) Mean Heart Rate
Day 59, n=2, 3
|
71.5 Beats per minute
Standard Deviation 9.19
|
73.7 Beats per minute
Standard Deviation 20.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Full 12-lead ECG were recorded with the participant in a semi-supine position to measure heart rate. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in ECG Mean Heart Rate
Day 42, n=2, 2
|
-8.0 Beats per minute
Standard Deviation 11.31
|
-0.5 Beats per minute
Standard Deviation 2.12
|
|
Change From Baseline in ECG Mean Heart Rate
Day 59, n=2, 3
|
2.5 Beats per minute
Standard Deviation 12.02
|
3.7 Beats per minute
Standard Deviation 9.50
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Full 12-lead ECGs were recorded with the participant in a semi-supine position to measure PR interval, QRS duration, QT interval and QTcB, calculated (machine read or manually).
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
PR Interval, Day 1, n=2, 3
|
139.0 Milliseconds
Standard Deviation 1.41
|
181.7 Milliseconds
Standard Deviation 23.16
|
|
Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
PR Interval, Day 42, n=2, 2
|
146.5 Milliseconds
Standard Deviation 7.78
|
192.5 Milliseconds
Standard Deviation 10.61
|
|
Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
PR Interval, Day 59, n=2, 3
|
146.5 Milliseconds
Standard Deviation 2.12
|
182.0 Milliseconds
Standard Deviation 18.00
|
|
Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
QRS Duration, Day 1, n=2, 3
|
87.0 Milliseconds
Standard Deviation 7.07
|
94.7 Milliseconds
Standard Deviation 5.03
|
|
Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
QRS Duration, Day 42, n=2, 2
|
88.5 Milliseconds
Standard Deviation 9.19
|
96.5 Milliseconds
Standard Deviation 10.61
|
|
Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
QRS Duration, Day 59, n=2, 3
|
87.0 Milliseconds
Standard Deviation 9.90
|
95.3 Milliseconds
Standard Deviation 7.02
|
|
Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
QT Interval, Day 1, n=2, 3
|
395.5 Milliseconds
Standard Deviation 6.36
|
391.3 Milliseconds
Standard Deviation 14.47
|
|
Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
QT Interval, Day 42, n=2, 2
|
413.5 Milliseconds
Standard Deviation 20.51
|
388.0 Milliseconds
Standard Deviation 11.31
|
|
Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
QT Interval, Day 59, n=2, 3
|
383.5 Milliseconds
Standard Deviation 44.55
|
382.3 Milliseconds
Standard Deviation 33.71
|
|
Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
QTcB Interval, Day 1, n=2, 3
|
424.0 Milliseconds
Standard Deviation 1.41
|
420.7 Milliseconds
Standard Deviation 31.79
|
|
Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
QTcB Interval, Day 42, n=2, 2
|
414.5 Milliseconds
Standard Deviation 27.58
|
393.0 Milliseconds
Standard Deviation 19.80
|
|
Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
QTcB Interval, Day 59, n=2, 3
|
416.5 Milliseconds
Standard Deviation 21.92
|
417.3 Milliseconds
Standard Deviation 33.32
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Full 12-lead ECGs were recorded with the participant in a semi-supine position to measure PR interval, QRS duration, QT (uncorrected) interval and QTcB, calculated (machine read or manually). Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in ECG Parameters- PR Interval, QRS Duration, and QT Interval and QTcB
PR Interval, Day 42, n=2, 2
|
7.5 Milliseconds
Standard Deviation 6.36
|
-2.0 Milliseconds
Standard Deviation 19.80
|
|
Change From Baseline in ECG Parameters- PR Interval, QRS Duration, and QT Interval and QTcB
PR Interval, Day 59, n=2, 3
|
7.5 Milliseconds
Standard Deviation 0.71
|
0.3 Milliseconds
Standard Deviation 16.86
|
|
Change From Baseline in ECG Parameters- PR Interval, QRS Duration, and QT Interval and QTcB
QRS Duration, Day 42, n=2, 2
|
1.5 Milliseconds
Standard Deviation 2.12
|
1.5 Milliseconds
Standard Deviation 3.54
|
|
Change From Baseline in ECG Parameters- PR Interval, QRS Duration, and QT Interval and QTcB
QRS Duration, Day 59, n=2, 3
|
0.0 Milliseconds
Standard Deviation 2.83
|
0.7 Milliseconds
Standard Deviation 2.31
|
|
Change From Baseline in ECG Parameters- PR Interval, QRS Duration, and QT Interval and QTcB
QT Interval, Day 42, n=2, 2
|
18.0 Milliseconds
Standard Deviation 14.14
|
-7.0 Milliseconds
Standard Deviation 7.07
|
|
Change From Baseline in ECG Parameters- PR Interval, QRS Duration, and QT Interval and QTcB
QT Interval, Day 59, n=2, 3
|
-12.0 Milliseconds
Standard Deviation 50.91
|
-9.0 Milliseconds
Standard Deviation 19.67
|
|
Change From Baseline in ECG Parameters- PR Interval, QRS Duration, and QT Interval and QTcB
QTcB Interval, Day 42, n=2, 2
|
-9.5 Milliseconds
Standard Deviation 26.16
|
-9.5 Milliseconds
Standard Deviation 13.44
|
|
Change From Baseline in ECG Parameters- PR Interval, QRS Duration, and QT Interval and QTcB
QTcB Interval, Day 59, n=2, 3
|
-7.5 Milliseconds
Standard Deviation 20.51
|
-3.3 Milliseconds
Standard Deviation 8.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including platelet count, leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Platelet count, Day 1, n=2, 3
|
199.0 Giga cells per Liter
Standard Deviation 63.64
|
191.7 Giga cells per Liter
Standard Deviation 68.13
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Platelet count, Day 42, n=2, 2
|
203.5 Giga cells per Liter
Standard Deviation 57.28
|
121.5 Giga cells per Liter
Standard Deviation 13.44
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Platelet count, Day 59, n=2, 3
|
193.0 Giga cells per Liter
Standard Deviation 41.01
|
50.08 Giga cells per Liter
Standard Deviation 50.08
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Leukocytes, Day 1, n=2, 3
|
5.05 Giga cells per Liter
Standard Deviation 1.202
|
6.30 Giga cells per Liter
Standard Deviation 2.117
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Leukocytes, Day 42, n=2, 2
|
6.05 Giga cells per Liter
Standard Deviation 2.616
|
5.75 Giga cells per Liter
Standard Deviation 2.051
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Leukocytes, Day 59, n=2, 3
|
5.30 Giga cells per Liter
Standard Deviation 1.414
|
7.20 Giga cells per Liter
Standard Deviation 2.261
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Basophils, Day 1, n=2, 3
|
0.045 Giga cells per Liter
Standard Deviation 0.0212
|
0.057 Giga cells per Liter
Standard Deviation 0.0503
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Basophils, Day 42, n=2, 2
|
0.045 Giga cells per Liter
Standard Deviation 0.0212
|
0.045 Giga cells per Liter
Standard Deviation 0.0212
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Basophils, Day 59, n=2, 3
|
0.035 Giga cells per Liter
Standard Deviation 0.0071
|
0.050 Giga cells per Liter
Standard Deviation 0.0400
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Eosinophils, Day 1, n=2, 3
|
0.295 Giga cells per Liter
Standard Deviation 0.1485
|
0.230 Giga cells per Liter
Standard Deviation 0.1353
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Eosinophils, Day 42, n=2, 2
|
0.300 Giga cells per Liter
Standard Deviation 0.1980
|
0.175 Giga cells per Liter
Standard Deviation 0.0778
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Eosinophils, Day 59, n=2, 3
|
0.245 Giga cells per Liter
Standard Deviation 0.1485
|
0.220 Giga cells per Liter
Standard Deviation 0.1311
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Lymphocytes, Day 1, n=2, 3
|
1.160 Giga cells per Liter
Standard Deviation 0.2404
|
2.037 Giga cells per Liter
Standard Deviation 1.4989
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Lymphocytes, Day 42, n=2, 2
|
1.275 Giga cells per Liter
Standard Deviation 0.2616
|
1.150 Giga cells per Liter
Standard Deviation 0.4808
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Lymphocytes, Day 59, n=2, 3
|
0.785 Giga cells per Liter
Standard Deviation 0.3748
|
2.033 Giga cells per Liter
Standard Deviation 1.3580
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Monocytes, Day 1, n=2, 3
|
0.400 Giga cells per Liter
Standard Deviation 0.0566
|
0.607 Giga cells per Liter
Standard Deviation 0.3147
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Monocytes, Day 42, n=2, 2
|
0.415 Giga cells per Liter
Standard Deviation 0.0071
|
0.445 Giga cells per Liter
Standard Deviation 0.2192
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Monocytes, Day 59, n=2, 3
|
0.415 Giga cells per Liter
Standard Deviation 0.0778
|
0.563 Giga cells per Liter
Standard Deviation 0.2574
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Neutrophils, Day 1, n=2, 3
|
3.160 Giga cells per Liter
Standard Deviation 1.3576
|
3.387 Giga cells per Liter
Standard Deviation 0.2053
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Neutrophils, Day 42, n=2, 2
|
4.010 Giga cells per Liter
Standard Deviation 2.6870
|
3.970 Giga cells per Liter
Standard Deviation 2.1920
|
|
Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Neutrophils, Day 59, n=2, 3
|
3.825 Giga cells per Liter
Standard Deviation 1.0112
|
4.343 Giga cells per Liter
Standard Deviation 1.0060
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count (Absolute), basophils, eosinophils, lymphocytes, monocytes and neutrophils. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Platelet count, Day 42, n=2, 2
|
4.5 Giga cells per Liter
Standard Deviation 6.36
|
-51.0 Giga cells per Liter
Standard Deviation 70.71
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Platelet count, Day 59, n=2, 3
|
-6.0 Giga cells per Liter
Standard Deviation 22.63
|
-26.3 Giga cells per Liter
Standard Deviation 51.98
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Leukocytes, Day 42, n=2, 2
|
1.00 Giga cells per Liter
Standard Deviation 1.414
|
0.65 Giga cells per Liter
Standard Deviation 2.616
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Leukocytes, Day 59, n=2, 3
|
0.25 Giga cells per Liter
Standard Deviation 0.212
|
0.90 Giga cells per Liter
Standard Deviation 1.054
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Basophils, Day 42, n=2, 2
|
0.000 Giga cells per Liter
Standard Deviation 0.0000
|
0.015 Giga cells per Liter
Standard Deviation 0.0071
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Basophils, Day 59, n=2, 3
|
-0.010 Giga cells per Liter
Standard Deviation 0.0283
|
-0.007 Giga cells per Liter
Standard Deviation 0.0115
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Eosinophils, Day 42, n=2, 2
|
0.005 Giga cells per Liter
Standard Deviation 0.0495
|
0.015 Giga cells per Liter
Standard Deviation 0.0071
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Eosinophils, Day 59, n=2, 3
|
-0.050 Giga cells per Liter
Standard Deviation 0.0000
|
-0.010 Giga cells per Liter
Standard Deviation 0.0100
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Lymphocytes, Day 42, n=2, 2
|
0.115 Giga cells per Liter
Standard Deviation 0.0212
|
-0.040 Giga cells per Liter
Standard Deviation 0.0424
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Lymphocytes, Day 59, n=2, 3
|
-0.375 Giga cells per Liter
Standard Deviation 0.6152
|
-0.003 Giga cells per Liter
Standard Deviation 0.1443
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Monocytes, Day 42, n=2, 2
|
0.015 Giga cells per Liter
Standard Deviation 0.0636
|
0.020 Giga cells per Liter
Standard Deviation 0.2263
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Monocytes, Day 59, n=2, 3
|
0.015 Giga cells per Liter
Standard Deviation 0.0212
|
-0.043 Giga cells per Liter
Standard Deviation 0.0586
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Neutrophils, Day 42, n=2, 2
|
0.850 Giga cells per Liter
Standard Deviation 1.3294
|
0.670 Giga cells per Liter
Standard Deviation 2.3900
|
|
Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Neutrophils, Day 59, n=2, 3
|
0.665 Giga cells per Liter
Standard Deviation 0.3465
|
0.957 Giga cells per Liter
Standard Deviation 1.0929
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including RBC count and RC.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC)
RBC, Day 1, n=2, 3
|
3.45 Trillion cells per liter
Standard Deviation 0.354
|
3.20 Trillion cells per liter
Standard Deviation 0.300
|
|
Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC)
RBC, Day 42, n=2, 2
|
3.30 Trillion cells per liter
Standard Deviation 0.283
|
3.65 Trillion cells per liter
Standard Deviation 0.071
|
|
Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC)
RBC, Day 59, n=2, 3
|
3.35 Trillion cells per liter
Standard Deviation 0.354
|
3.63 Trillion cells per liter
Standard Deviation 0.493
|
|
Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC)
RC, Day 1, n=2, 3
|
0.04090 Trillion cells per liter
Standard Deviation 0.018102
|
0.06090 Trillion cells per liter
Standard Deviation 0.038112
|
|
Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC)
RC, Day 42, n=2, 2
|
0.04610 Trillion cells per liter
Standard Deviation 0.023052
|
0.07970 Trillion cells per liter
Standard Deviation 0.057983
|
|
Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC)
RC, Day 59, n=2, 3
|
0.03490 Trillion cells per liter
Standard Deviation 0.014708
|
0.04580 Trillion cells per liter
Standard Deviation 0.049537
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including RBC count and RC. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in Hematology Parameters of RBC Count and RC
RBC, Day 42, n=2, 2
|
-0.15 Trillion cells per liter
Standard Deviation 0.071
|
0.60 Trillion cells per liter
Standard Deviation 0.141
|
|
Change From Baseline in Hematology Parameters of RBC Count and RC
RBC, Day 59, n=2, 3
|
-0.10 Trillion cells per liter
Standard Deviation 0.000
|
0.43 Trillion cells per liter
Standard Deviation 0.252
|
|
Change From Baseline in Hematology Parameters of RBC Count and RC
RC, Day 42, n=2, 2
|
0.00520 Trillion cells per liter
Standard Deviation 0.004950
|
0.00815 Trillion cells per liter
Standard Deviation 0.010819
|
|
Change From Baseline in Hematology Parameters of RBC Count and RC
RC, Day 59, n=2, 3
|
-0.00600 Trillion cells per liter
Standard Deviation 0.003394
|
-0.01510 Trillion cells per liter
Standard Deviation 0.011467
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including hemoglobin and MCHC.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)
Hemoglobin, Day 1, n=2, 3
|
10.60 Grams per deciliter
Standard Deviation 0.849
|
9.77 Grams per deciliter
Standard Deviation 0.586
|
|
Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)
Hemoglobin, Day 42, n=2, 2
|
10.45 Grams per deciliter
Standard Deviation 0.778
|
11.40 Grams per deciliter
Standard Deviation 0.424
|
|
Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)
Hemoglobin, Day 59, n=2, 3
|
10.40 Grams per deciliter
Standard Deviation 0.849
|
11.27 Grams per deciliter
Standard Deviation 1.002
|
|
Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)
MCHC, Day 1, n=2, 3
|
34.10 Grams per deciliter
Standard Deviation 0.000
|
34.23 Grams per deciliter
Standard Deviation 0.351
|
|
Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)
MCHC, Day 42, n=2, 2
|
34.10 Grams per deciliter
Standard Deviation 0.141
|
33.75 Grams per deciliter
Standard Deviation 1.909
|
|
Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)
MCHC, Day 59, n=2, 3
|
34.00 Grams per deciliter
Standard Deviation 0.141
|
34.33 Grams per deciliter
Standard Deviation 1.447
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including hemoglobin and MCHC. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in Hematology Parameters- Hemoglobin and MCHC
Hemoglobin, Day 42, n=2, 2
|
-0.15 Grams per deciliter
Standard Deviation 0.071
|
1.85 Grams per deciliter
Standard Deviation 0.212
|
|
Change From Baseline in Hematology Parameters- Hemoglobin and MCHC
Hemoglobin, Day 59, n=2, 3
|
-0.20 Grams per deciliter
Standard Deviation 0.000
|
1.50 Grams per deciliter
Standard Deviation 0.520
|
|
Change From Baseline in Hematology Parameters- Hemoglobin and MCHC
MCHC, Day 42, n=2, 2
|
0.00 Grams per deciliter
Standard Deviation 0.141
|
-0.65 Grams per deciliter
Standard Deviation 1.626
|
|
Change From Baseline in Hematology Parameters- Hemoglobin and MCHC
MCHC, Day 59, n=2, 3
|
-0.10 Grams per deciliter
Standard Deviation 0.141
|
0.10 Grams per deciliter
Standard Deviation 1.127
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including hematocrit.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of Hematology Parameter: Hematocrit
Day 1, n=2, 3
|
0.3105 Proportion of red blood cells in blood
Standard Deviation 0.02616
|
0.2850 Proportion of red blood cells in blood
Standard Deviation 0.01769
|
|
Absolute Values of Hematology Parameter: Hematocrit
Day 42, n=2, 2
|
0.3065 Proportion of red blood cells in blood
Standard Deviation 0.02475
|
0.3385 Proportion of red blood cells in blood
Standard Deviation 0.00636
|
|
Absolute Values of Hematology Parameter: Hematocrit
Day 59, n=2, 3
|
0.3065 Proportion of red blood cells in blood
Standard Deviation 0.02475
|
0.3277 Proportion of red blood cells in blood
Standard Deviation 0.03412
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including hematocrit. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hematocrit
Day 42, n=2, 2
|
-0.0040 Proportion of red blood cells in blood
Standard Deviation 0.00141
|
0.0615 Proportion of red blood cells in blood
Standard Deviation 0.02192
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Day 59, n=2, 3
|
-0.0040 Proportion of red blood cells in blood
Standard Deviation 0.00141
|
0.0427 Proportion of red blood cells in blood
Standard Deviation 0.02212
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including RDW.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of Hematology Parameter of Red Blood Cell Distribution Width (RDW)
Day 1, n=2, 3
|
0.3105 Percentage of width
Standard Deviation 0.02616
|
0.2850 Percentage of width
Standard Deviation 0.01769
|
|
Absolute Values of Hematology Parameter of Red Blood Cell Distribution Width (RDW)
Day 42, n=2, 2
|
13.45 Percentage of width
Standard Deviation 0.212
|
14.00 Percentage of width
Standard Deviation 0.424
|
|
Absolute Values of Hematology Parameter of Red Blood Cell Distribution Width (RDW)
Day 59, n=2, 3
|
13.20 Percentage of width
Standard Deviation 0.141
|
13.70 Percentage of width
Standard Deviation 0.200
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including RDW. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in RDW
Day 42, n=2, 2
|
0.00 Percentage of width
Standard Deviation 0.424
|
1.15 Percentage of width
Standard Deviation 0.636
|
|
Change From Baseline in RDW
Day 59, n=2, 3
|
-0.25 Percentage of width
Standard Deviation 0.354
|
0.70 Percentage of width
Standard Deviation 0.436
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including MCH.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH)
Day 1, n=2, 3
|
30.95 Picograms
Standard Deviation 0.354
|
30.67 Picograms
Standard Deviation 1.457
|
|
Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH)
Day 42, n=2, 2
|
31.40 Picograms
Standard Deviation 0.424
|
31.40 Picograms
Standard Deviation 0.707
|
|
Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH)
Day 59, n=2, 3
|
31.10 Picograms
Standard Deviation 0.141
|
30.93 Picograms
Standard Deviation 1.716
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including MCH. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in Hematology Parameter of MCH
Day 42, n=2, 2
|
0.45 Picograms
Standard Deviation 0.071
|
-0.10 Picograms
Standard Deviation 0.990
|
|
Change From Baseline in Hematology Parameter of MCH
Day 59, n=2, 3
|
0.15 Picograms
Standard Deviation 0.212
|
0.27 Picograms
Standard Deviation 0.862
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including MCV.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV)
Day 1, n=2, 3
|
91.0 Femtoliters
Standard Deviation 1.41
|
89.7 Femtoliters
Standard Deviation 3.51
|
|
Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV)
Day 42, n=2, 2
|
92.0 Femtoliters
Standard Deviation 1.41
|
93.0 Femtoliters
Standard Deviation 2.83
|
|
Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV)
Day 59, n=2, 3
|
91.5 Femtoliters
Standard Deviation 0.71
|
90.0 Femtoliters
Standard Deviation 3.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected for the analysis of hematology parameters including MCV. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in Hematology Parameter of MCV
Day 42, n=2, 2
|
1.0 Femtoliters
Standard Deviation 0.00
|
1.5 Femtoliters
Standard Deviation 0.71
|
|
Change From Baseline in Hematology Parameter of MCV
Day 59, n=2, 3
|
0.5 Femtoliters
Standard Deviation 0.71
|
0.3 Femtoliters
Standard Deviation 0.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples will be collected for the analysis of clinical chemistry parameters including; sodium, potassium, carbon-dioxide (total), chloride, glucose and urea.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Chloride, Day 1, n=2, 3
|
108.0 Millimoles per Liter
Standard Deviation 0.00
|
105.7 Millimoles per Liter
Standard Deviation 5.03
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Sodium, Day 1, n=2, 3
|
140.0 Millimoles per Liter
Standard Deviation 1.41
|
136.7 Millimoles per Liter
Standard Deviation 0.58
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Sodium, Day 42, n=2, 2
|
139.5 Millimoles per Liter
Standard Deviation 3.54
|
135.0 Millimoles per Liter
Standard Deviation 7.07
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Sodium, Day 59, n=2, 3
|
138.5 Millimoles per Liter
Standard Deviation 0.71
|
136.0 Millimoles per Liter
Standard Deviation 2.65
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Potassium, Day 1, n=2, 3
|
4.70 Millimoles per Liter
Standard Deviation 0.141
|
5.03 Millimoles per Liter
Standard Deviation 0.757
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Potassium, Day 42, n=2, 2
|
4.55 Millimoles per Liter
Standard Deviation 0.495
|
5.15 Millimoles per Liter
Standard Deviation 0.495
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Potassium, Day 59, n=2, 3
|
4.45 Millimoles per Liter
Standard Deviation 0.071
|
4.77 Millimoles per Liter
Standard Deviation 0.306
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Carbon-dioxide (total), Day 1, n=2, 3
|
20.5 Millimoles per Liter
Standard Deviation 3.54
|
19.0 Millimoles per Liter
Standard Deviation 3.46
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Carbon-dioxide (total), Day 42, n=2, 2
|
22.0 Millimoles per Liter
Standard Deviation 1.41
|
19.0 Millimoles per Liter
Standard Deviation 0.00
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Carbon-dioxide (total), Day 59, n=2, 3
|
22.5 Millimoles per Liter
Standard Deviation 2.12
|
21.0 Millimoles per Liter
Standard Deviation 2.00
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Chloride, Day 42, n=2, 2
|
108.0 Millimoles per Liter
Standard Deviation 4.24
|
104.0 Millimoles per Liter
Standard Deviation 9.90
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Chloride, Day 59, n=2, 3
|
108.0 Millimoles per Liter
Standard Deviation 2.83
|
104.7 Millimoles per Liter
Standard Deviation 3.51
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Glucose, Day 1, n=2, 3
|
7.60 Millimoles per Liter
Standard Deviation 3.111
|
6.40 Millimoles per Liter
Standard Deviation 4.424
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Glucose, Day 42, n=2, 2
|
6.95 Millimoles per Liter
Standard Deviation 2.333
|
12.50 Millimoles per Liter
Standard Deviation 12.162
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Glucose, Day 59, n=2, 3
|
7.45 Millimoles per Liter
Standard Deviation 4.172
|
10.10 Millimoles per Liter
Standard Deviation 7.066
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Urea, Day 1, n=2, 3
|
18.00 Millimoles per Liter
Standard Deviation 2.828
|
16.67 Millimoles per Liter
Standard Deviation 5.508
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Urea, Day 42, n=2, 2
|
16.75 Millimoles per Liter
Standard Deviation 2.475
|
21.00 Millimoles per Liter
Standard Deviation 0.707
|
|
Absolute Values of Clinical Chemistry Parameters of Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Urea, Day 59, n=2, 3
|
16.50 Millimoles per Liter
Standard Deviation 0.707
|
19.33 Millimoles per Liter
Standard Deviation 5.795
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples will be collected for the analysis of clinical chemistry parameters including; sodium, potassium, carbon-dioxide (total), chloride, glucose and urea. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Sodium, Day 42, n=2, 2
|
-0.5 Millimoles per Liter
Standard Deviation 4.95
|
-1.5 Millimoles per Liter
Standard Deviation 6.36
|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Sodium, Day 59, n=2, 3
|
-1.5 Millimoles per Liter
Standard Deviation 2.12
|
-0.7 Millimoles per Liter
Standard Deviation 2.31
|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Potassium, Day 42, n=2, 2
|
-0.15 Millimoles per Liter
Standard Deviation 0.354
|
-0.05 Millimoles per Liter
Standard Deviation 0.495
|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Potassium, Day 59, n=2, 3
|
-0.25 Millimoles per Liter
Standard Deviation 0.071
|
-0.27 Millimoles per Liter
Standard Deviation 0.503
|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Carbon-dioxide (total), Day 42, n=2, 2
|
1.5 Millimoles per Liter
Standard Deviation 4.95
|
1.0 Millimoles per Liter
Standard Deviation 4.24
|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Carbon-dioxide (total), Day 59, n=2, 3
|
2.0 Millimoles per Liter
Standard Deviation 1.41
|
2.0 Millimoles per Liter
Standard Deviation 2.00
|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Chloride, Day 42, n=2, 2
|
0.0 Millimoles per Liter
Standard Deviation 4.24
|
-2.0 Millimoles per Liter
Standard Deviation 2.83
|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Chloride, Day 59, n=2, 3
|
0.0 Millimoles per Liter
Standard Deviation 2.83
|
1.73 Millimoles per Liter
Standard Deviation 1.73
|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Glucose, Day 42, n=2, 2
|
-0.65 Millimoles per Liter
Standard Deviation 0.778
|
4.25 Millimoles per Liter
Standard Deviation 7.849
|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Glucose, Day 59, n=2, 3
|
-0.15 Millimoles per Liter
Standard Deviation 1.061
|
3.70 Millimoles per Liter
Standard Deviation 3.477
|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Urea, Day 42, n=2, 2
|
-1.25 Millimoles per Liter
Standard Deviation 5.303
|
3.00 Millimoles per Liter
Standard Deviation 7.778
|
|
Change From Baseline in Clinical Chemistry Parameter: Sodium, Potassium, Carbon-dioxide (Total), Chloride, Glucose and Urea
Urea, Day 59, n=2, 3
|
-1.50 Millimoles per Liter
Standard Deviation 3.536
|
2.67 Millimoles per Liter
Standard Deviation 2.754
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples will be collected for the analysis of clinical chemistry parameters including; creatinine.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of Clinical Chemistry Parameters of Creatinine
Creatinine, Day 42, n=2, 2
|
249.75 Micromoles per Liter
Standard Deviation 15.627
|
272.25 Micromoles per Liter
Standard Deviation 88.742
|
|
Absolute Values of Clinical Chemistry Parameters of Creatinine
Creatinine, Day 1, n=2, 3
|
246.65 Micromoles per Liter
Standard Deviation 9.970
|
225.40 Micromoles per Liter
Standard Deviation 74.164
|
|
Absolute Values of Clinical Chemistry Parameters of Creatinine
Creatinine, Day 59, n=2, 3
|
260.35 Micromoles per Liter
Standard Deviation 8.132
|
245.17 Micromoles per Liter
Standard Deviation 91.086
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples will be collected for the analysis of clinical chemistry parameters including; creatinine. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Creatinine, Day 42, n=2, 2
|
3.10 Micromoles per Liter
Standard Deviation 5.657
|
36.70 Micromoles per Liter
Standard Deviation 13.152
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Creatinine, Day 59, n=2, 3
|
13.70 Micromoles per Liter
Standard Deviation 18.102
|
19.77 Micromoles per Liter
Standard Deviation 33.416
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 14, 28, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples will be collected for the analysis of clinical chemistry parameters including; bilirubin (direct/indirect and total).
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Indirect Bilirubin, Day 59, n=2, 2
|
3.0 Micromoles per Liter
Standard Deviation 1.41
|
5.0 Micromoles per Liter
Standard Deviation 1.41
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Bilirubin total, Day 1, n=2, 3
|
5.0 Micromoles per Liter
Standard Deviation 1.41
|
6.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Bilirubin total, Day 14, n=2, 3
|
5.0 Micromoles per Liter
Standard Deviation 1.41
|
7.3 Micromoles per Liter
Standard Deviation 1.15
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Bilirubin total, Day 28, n=2, 3
|
6.0 Micromoles per Liter
Standard Deviation 0.00
|
6.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Bilirubin total, Day 42, n=2, 2
|
6.0 Micromoles per Liter
Standard Deviation 0.00
|
9.0 Micromoles per Liter
Standard Deviation 4.24
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Bilirubin total, Day 59, n=2, 3
|
5.0 Micromoles per Liter
Standard Deviation 1.41
|
6.7 Micromoles per Liter
Standard Deviation 1.15
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Direct Bilirubin, Day 1, n=2, 2
|
1.0 Micromoles per Liter
Standard Deviation 1.41
|
2.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Direct Bilirubin, Day 14, n=2, 2
|
1.0 Micromoles per Liter
Standard Deviation 1.41
|
2.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Direct Bilirubin, Day 28, n=2, 2
|
1.0 Micromoles per Liter
Standard Deviation 1.41
|
2.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Direct Bilirubin, Day 42, n=2, 1
|
2.0 Micromoles per Liter
Standard Deviation 0.00
|
2.0 Micromoles per Liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Direct Bilirubin, Day 59, n=2, 2
|
2.0 Micromoles per Liter
Standard Deviation 0.00
|
2.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Indirect Bilirubin, Day 1, n=2, 2
|
4.0 Micromoles per Liter
Standard Deviation 0.00
|
4.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Indirect Bilirubin, Day 14, n=2, 2
|
4.0 Micromoles per Liter
Standard Deviation 0.00
|
5.0 Micromoles per Liter
Standard Deviation 1.41
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Indirect Bilirubin, Day 28, n=2, 2
|
5.0 Micromoles per Liter
Standard Deviation 1.41
|
4.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Absolute Values of Clinical Chemistry Parameters of Bilirubin (Direct/Indirect and Total)
Indirect Bilirubin, Day 42, n=2, 1
|
4.0 Micromoles per Liter
Standard Deviation 0.00
|
10.0 Micromoles per Liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 14, 28, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples will be collected for the analysis of clinical chemistry parameters including; creatinine and bilirubin (direct/indirect and total). Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)
Bilirubin total, Day 28, n=2, 3
|
1.0 Micromoles per Liter
Standard Deviation 1.41
|
0.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)
Bilirubin total, Day 14, n=2, 3
|
0.0 Micromoles per Liter
Standard Deviation 0.00
|
1.3 Micromoles per Liter
Standard Deviation 1.15
|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)
Bilirubin total, Day 42, n=2, 2
|
1.0 Micromoles per Liter
Standard Deviation 1.41
|
3.0 Micromoles per Liter
Standard Deviation 4.24
|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)
Bilirubin total, Day 59, n=2, 3
|
0.0 Micromoles per Liter
Standard Deviation 0.00
|
0.7 Micromoles per Liter
Standard Deviation 1.15
|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)
Direct Bilirubin, Day 14, n=2, 2
|
0.0 Micromoles per Liter
Standard Deviation 0.00
|
0.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)
Direct Bilirubin, Day 28, n=2, 2
|
0.0 Micromoles per Liter
Standard Deviation 0.00
|
0.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)
Direct Bilirubin, Day 42, n=2, 1
|
1.0 Micromoles per Liter
Standard Deviation 1.41
|
0.0 Micromoles per Liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)
Direct Bilirubin, Day 59, n=2, 2
|
1.0 Micromoles per Liter
Standard Deviation 1.41
|
0.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)
Indirect Bilirubin, Day 14, n=2, 2
|
0.0 Micromoles per Liter
Standard Deviation 0.00
|
1.0 Micromoles per Liter
Standard Deviation 1.41
|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)
Indirect Bilirubin, Day 28, n=2, 2
|
1.0 Micromoles per Liter
Standard Deviation 1.41
|
0.0 Micromoles per Liter
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)
Indirect Bilirubin, Day 42, n=2, 1
|
0.0 Micromoles per Liter
Standard Deviation 0.00
|
6.0 Micromoles per Liter
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameter: Bilirubin (Direct/Indirect and Total)
Indirect Bilirubin, Day 59, n=2, 2
|
-1.0 Micromoles per Liter
Standard Deviation 1.41
|
1.0 Micromoles per Liter
Standard Deviation 1.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 14, 28, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples will be collected for the analysis of clinical chemistry parameters including; ALT, ALP and AST.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
AST, Day 28, n=2, 3
|
18.0 International units per Liter
Standard Deviation 9.90
|
18.7 International units per Liter
Standard Deviation 7.09
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
ALT, Day 1, n=2, 3
|
21.0 International units per Liter
Standard Deviation 4.24
|
26.7 International units per Liter
Standard Deviation 7.02
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
ALT, Day 14, n=2, 3
|
15.0 International units per Liter
Standard Deviation 4.24
|
20.3 International units per Liter
Standard Deviation 6.81
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
ALT, Day 28, n=2, 3
|
15.5 International units per Liter
Standard Deviation 4.95
|
18.3 International units per Liter
Standard Deviation 8.08
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
ALT, Day 42, n=2, 2
|
16.0 International units per Liter
Standard Deviation 4.24
|
22.0 International units per Liter
Standard Deviation 9.90
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
ALT, Day 59, n=2, 3
|
20.5 International units per Liter
Standard Deviation 10.61
|
23.3 International units per Liter
Standard Deviation 8.08
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
ALP, Day 1, n=2, 3
|
113.5 International units per Liter
Standard Deviation 61.52
|
95.0 International units per Liter
Standard Deviation 42.44
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
ALP, Day 14, n=2, 3
|
97.0 International units per Liter
Standard Deviation 42.43
|
91.0 International units per Liter
Standard Deviation 33.87
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
ALP, Day 28, n=2, 3
|
99.5 International units per Liter
Standard Deviation 45.96
|
91.7 International units per Liter
Standard Deviation 38.40
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
ALP, Day 42, n=2, 2
|
99.0 International units per Liter
Standard Deviation 39.60
|
100.5 International units per Liter
Standard Deviation 37.48
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
ALP, Day 59, n=2, 3
|
108.5 International units per Liter
Standard Deviation 55.86
|
90.3 International units per Liter
Standard Deviation 29.26
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
AST, Day 1, n=2, 3
|
19.5 International units per Liter
Standard Deviation 7.78
|
21.7 International units per Liter
Standard Deviation 1.53
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
AST, Day 14, n=2, 3
|
16.5 International units per Liter
Standard Deviation 7.78
|
18.3 International units per Liter
Standard Deviation 3.51
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
AST, Day 42, n=2, 2
|
17.5 International units per Liter
Standard Deviation 10.61
|
16.5 International units per Liter
Standard Deviation 4.95
|
|
Absolute Values of Clinical Chemistry Parameters of Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST)
AST, Day 59, n=2, 3
|
20.5 International units per Liter
Standard Deviation 10.61
|
19.3 International units per Liter
Standard Deviation 6.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 14, 28, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples will be collected for the analysis of clinical chemistry parameters including; ALT, ALP and AST. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: ALT, ALP and AST
ALT, Day 14, n=2, 3
|
-6.0 International units per Liter
Standard Deviation 0.00
|
-6.3 International units per Liter
Standard Deviation 1.53
|
|
Change From Baseline in Clinical Chemistry Parameter: ALT, ALP and AST
ALT, Day 28, n=2, 3
|
-5.5 International units per Liter
Standard Deviation 0.71
|
-8.3 International units per Liter
Standard Deviation 1.15
|
|
Change From Baseline in Clinical Chemistry Parameter: ALT, ALP and AST
ALT, Day 42, n=2, 2
|
-5.0 International units per Liter
Standard Deviation 0.00
|
-5.0 International units per Liter
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Chemistry Parameter: ALT, ALP and AST
ALT, Day 59, n=2, 3
|
-0.5 International units per Liter
Standard Deviation 6.36
|
-3.3 International units per Liter
Standard Deviation 4.62
|
|
Change From Baseline in Clinical Chemistry Parameter: ALT, ALP and AST
ALP, Day 14, n=2, 3
|
-16.5 International units per Liter
Standard Deviation 19.09
|
-4.0 International units per Liter
Standard Deviation 12.12
|
|
Change From Baseline in Clinical Chemistry Parameter: ALT, ALP and AST
ALP, Day 28, n=2, 3
|
-14.0 International units per Liter
Standard Deviation 15.56
|
-3.3 International units per Liter
Standard Deviation 4.04
|
|
Change From Baseline in Clinical Chemistry Parameter: ALT, ALP and AST
ALP, Day 42, n=2, 2
|
-14.5 International units per Liter
Standard Deviation 21.92
|
-6.5 International units per Liter
Standard Deviation 14.85
|
|
Change From Baseline in Clinical Chemistry Parameter: ALT, ALP and AST
ALP, Day 59, n=2, 3
|
-5.0 International units per Liter
Standard Deviation 5.66
|
-4.7 International units per Liter
Standard Deviation 13.61
|
|
Change From Baseline in Clinical Chemistry Parameter: ALT, ALP and AST
AST, Day 14, n=2, 3
|
-3.0 International units per Liter
Standard Deviation 0.00
|
-3.3 International units per Liter
Standard Deviation 2.08
|
|
Change From Baseline in Clinical Chemistry Parameter: ALT, ALP and AST
AST, Day 28, n=2, 3
|
-1.5 International units per Liter
Standard Deviation 2.12
|
-3.0 International units per Liter
Standard Deviation 6.00
|
|
Change From Baseline in Clinical Chemistry Parameter: ALT, ALP and AST
AST, Day 42, n=2, 2
|
-2.0 International units per Liter
Standard Deviation 2.83
|
-5.0 International units per Liter
Standard Deviation 2.83
|
|
Change From Baseline in Clinical Chemistry Parameter: ALT, ALP and AST
AST, Day 59, n=2, 3
|
1.0 International units per Liter
Standard Deviation 2.83
|
-2.3 International units per Liter
Standard Deviation 5.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 14, 28, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples will be collected for the analysis of clinical chemistry parameters including; Albumin.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Absolute Values of Clinical Chemistry Parameters of Albumin
Day 42, n=2, 2
|
35.5 Grams per Liter
Standard Deviation 3.54
|
38.5 Grams per Liter
Standard Deviation 0.71
|
|
Absolute Values of Clinical Chemistry Parameters of Albumin
Day 1, n=2, 3
|
37.0 Grams per Liter
Standard Deviation 5.66
|
41.7 Grams per Liter
Standard Deviation 2.31
|
|
Absolute Values of Clinical Chemistry Parameters of Albumin
Day 14, n=2, 3
|
36.5 Grams per Liter
Standard Deviation 2.12
|
40.7 Grams per Liter
Standard Deviation 3.06
|
|
Absolute Values of Clinical Chemistry Parameters of Albumin
Day 28, n=2, 3
|
35.5 Grams per Liter
Standard Deviation 3.54
|
39.3 Grams per Liter
Standard Deviation 3.21
|
|
Absolute Values of Clinical Chemistry Parameters of Albumin
Day 59, n=2, 3
|
36.5 Grams per Liter
Standard Deviation 6.36
|
40.3 Grams per Liter
Standard Deviation 1.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and at Days 14, 28, 42 and 59Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples will be collected for the analysis of clinical chemistry parameters including; Albumin. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Daprodustat
n=2 Participants
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 Participants
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Albumin
Day 28, n=2, 3
|
-0.15 Grams per Liter
Standard Deviation 0.212
|
-0.23 Grams per Liter
Standard Deviation 0.321
|
|
Change From Baseline in Clinical Chemistry Parameter: Albumin
Day 42, n=2, 2
|
-0.15 Grams per Liter
Standard Deviation 0.212
|
-0.25 Grams per Liter
Standard Deviation 0.354
|
|
Change From Baseline in Clinical Chemistry Parameter: Albumin
Day 14, n=2, 3
|
-0.05 Grams per Liter
Standard Deviation 0.354
|
-0.10 Grams per Liter
Standard Deviation 0.200
|
|
Change From Baseline in Clinical Chemistry Parameter: Albumin
Day 59, n=2, 3
|
-0.05 Grams per Liter
Standard Deviation 0.071
|
-0.13 Grams per Liter
Standard Deviation 0.153
|
Adverse Events
Daprodustat
Darbepoetin Alfa
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Daprodustat
n=2 participants at risk
Participants were randomized to receive 2 milligram (mg) daprodustat tablets once daily via oral route for a period of 41 days.
|
Darbepoetin Alfa
n=3 participants at risk
Participants were randomized to receive darbepoetin alfa solution for injection, administered as a single subcutaneous injection, once every two weeks (Days 1, 14 and 28).
|
|---|---|---|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/2 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/2 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Bilateral foot discomfort secondary to Gout
|
0.00%
0/2 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Swollen right foot secondary to Gout
|
0.00%
0/2 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/2 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Non-SAEs and SAEs were collected from the start of the treatment and Up to 59 days
Non-SAEs and SAEs were collected in the Safety Population which comprised of participants who received at least one dose of study 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