Trial Outcomes & Findings for Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P) (NCT NCT05682326)
NCT ID: NCT05682326
Last Updated: 2025-11-10
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other situations as per medical and scientific judgement of the Investigator.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4 participants
Primary outcome timeframe
Up to 56 weeks
Results posted on
2025-11-10
Participant Flow
Participants were enrolled into two sub-trials based on dialysis status under a master protocol. The non-dialysis (ND) sub-trial enrolled pediatric participants with anemia associated with chronic kidney disease (CKD) not yet requiring dialysis in non-US countries. The dialysis (D) sub-trial enrolled pediatric participants with anemia associated with CKD requiring dialysis in non-US countries. Recruitment was conducted separately for each sub-trial.
A total of 4 participants were enrolled. As pre-specified in protocol design, data for the 2 sub-trials (ND and D) have been presented in two arms for this study.
Participant milestones
| Measure |
Participants Requiring Dialysis (D)
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 milligram (mg), to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Participants Requiring Dialysis (D)
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 milligram (mg), to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
Baseline characteristics by cohort
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
12 to <18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
All Other Races
|
2 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to 56 weeksPopulation: The analysis was performed on the Safety Set that included all participants who were enrolled and took at least one dose of study medication.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other situations as per medical and scientific judgement of the Investigator.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
2 Participants
|
2 Participants
|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 56 weeksPopulation: Safety Set
AESIs are AEs of scientific interest specific to the drug class as per investigator assessment. AESI included: Death, Myocardial Infarction (MI), stroke, Heart Failure (HF), thromboembolic events, thrombosis of vascular access, Thrombosis and/or tissue ischemia secondary to excessive erythropoiesis, New diagnosis of hypertension or worsening of existing hypertension, Cancer related mortality and tumor progression and recurrence, Esophageal and gastric erosions. Number of participants with any AESIs have been presented.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Number of Participants With Adverse Event of Special Interests (AESIs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: Safety Set
All AEs leading to study intervention discontinuation were collected. Number of participants with any AEs leading to study intervention discontinuation have been presented
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Number of Participants With AEs Leading to Study Intervention Discontinuation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 16
|
-0.0200 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0185 Percentage of red blood cells in blood
Standard Deviation 0.03889
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 20
|
0.0000 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0005 Percentage of red blood cells in blood
Standard Deviation 0.01909
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 24
|
0.0050 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0060 Percentage of red blood cells in blood
Standard Deviation 0.02687
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 28
|
0.0340 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0050 Percentage of red blood cells in blood
Standard Deviation 0.03536
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 4
|
0.0160 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0030 Percentage of red blood cells in blood
Standard Deviation 0.03818
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 44
|
-0.0020 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0060 Percentage of red blood cells in blood
Standard Deviation 0.03677
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 32
|
0.0350 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0370 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 52
|
-0.0320 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0020 Percentage of red blood cells in blood
Standard Deviation 0.01980
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 8
|
0.0530 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0025 Percentage of red blood cells in blood
Standard Deviation 0.03889
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 12
|
-0.0280 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0135 Percentage of red blood cells in blood
Standard Deviation 0.01485
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 36
|
0.0070 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0095 Percentage of red blood cells in blood
Standard Deviation 0.02333
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 40
|
-0.0220 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0270 Percentage of red blood cells in blood
Standard Deviation 0.04667
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 48
|
—
|
0.0035 Percentage of red blood cells in blood
Standard Deviation 0.01909
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the hematology parameter: Reticulocytes/Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 8
|
-0.0020 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0031 Ratio of Reticulocytes to Erythrocytes
Standard Deviation 0.00134
|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 28
|
0.0040 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0007 Ratio of Reticulocytes to Erythrocytes
Standard Deviation 0.00467
|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 36
|
0.0020 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0010 Ratio of Reticulocytes to Erythrocytes
Standard Deviation 0.00573
|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 40
|
0.0070 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0020 Ratio of Reticulocytes to Erythrocytes
Standard Deviation 0.00849
|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 4
|
0.0080 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0039 Ratio of Reticulocytes to Erythrocytes
Standard Deviation 0.00686
|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 12
|
0.0060 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0012 Ratio of Reticulocytes to Erythrocytes
Standard Deviation 0.00594
|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 16
|
0.0100 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0024 Ratio of Reticulocytes to Erythrocytes
Standard Deviation 0.00481
|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 20
|
0.0110 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0001 Ratio of Reticulocytes to Erythrocytes
Standard Deviation 0.00693
|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 24
|
0.0060 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0020 Ratio of Reticulocytes to Erythrocytes
Standard Deviation 0.00700
|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 32
|
0.0030 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0037 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 44
|
0.0100 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0010 Ratio of Reticulocytes to Erythrocytes
Standard Deviation 0.00714
|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 48
|
—
|
0.0026 Ratio of Reticulocytes to Erythrocytes
Standard Deviation 0.00771
|
|
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Week 52
|
0.0040 Ratio of Reticulocytes to Erythrocytes
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0018 Ratio of Reticulocytes to Erythrocytes
Standard Deviation 0.00453
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 36
|
0.030 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.050 Trillion cells per Liter (10^12 cells/L)
Standard Deviation 0.3111
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 40
|
-0.330 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.310 Trillion cells per Liter (10^12 cells/L)
Standard Deviation 0.4808
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 44
|
-0.260 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.080 Trillion cells per Liter (10^12 cells/L)
Standard Deviation 0.5515
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 48
|
—
|
-0.025 Trillion cells per Liter (10^12 cells/L)
Standard Deviation 0.2758
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 52
|
-0.490 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.050 Trillion cells per Liter (10^12 cells/L)
Standard Deviation 0.2687
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 8
|
0.480 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.045 Trillion cells per Liter (10^12 cells/L)
Standard Deviation 0.4313
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 24
|
0.030 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.025 Trillion cells per Liter (10^12 cells/L)
Standard Deviation 0.3889
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 4
|
0.130 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.060 Trillion cells per Liter (10^12 cells/L)
Standard Deviation 0.4243
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 12
|
-0.350 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.060 Trillion cells per Liter (10^12 cells/L)
Standard Deviation 0.2546
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 16
|
-0.350 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.280 Trillion cells per Liter (10^12 cells/L)
Standard Deviation 0.5374
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 20
|
0.010 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.050 Trillion cells per Liter (10^12 cells/L)
Standard Deviation 0.2970
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 28
|
0.250 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.095 Trillion cells per Liter (10^12 cells/L)
Standard Deviation 0.4879
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 32
|
0.350 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.350 Trillion cells per Liter (10^12 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet count. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 28
|
0.0182 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0003 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.01458
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 16
|
0.0239 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.1184 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.15326
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 52
|
-0.0628 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0390 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.00136
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 4
|
0.2799 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.2606 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.01499
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 8
|
0.4370 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.4114 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.49299
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 16
|
-0.2907 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.2009 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.40885
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 24
|
-0.1535 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.3050 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.58684
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 4
|
0.0408 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0318 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.03079
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 36
|
-0.0410 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0596 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.01360
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 16
|
-1.7681 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.3315 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.27070
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 24
|
-1.2919 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.2346 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.30353
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 36
|
1.2095 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.4269 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.70272
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 48
|
—
|
0.310 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.4384
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 32
|
6.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 4
|
0.0120 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0007 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.01509
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 8
|
-0.0177 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0087 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.01232
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 12
|
-0.0011 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0093 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.01312
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 16
|
-0.0062 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0038 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.02292
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 20
|
0.0085 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0162 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.02295
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 44
|
-0.0091 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0001 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.00017
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 24
|
-0.0044 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0066 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.02353
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 32
|
-0.0209 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0314 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 36
|
-0.0091 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0051 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.02139
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 40
|
-0.0020 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0063 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.00522
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 48
|
—
|
0.0059 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.00833
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Basophils: Week 52
|
0.0012 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0001 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.00008
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 4
|
0.0146 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.4193 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.63542
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 8
|
-0.0962 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.2385 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.30899
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 12
|
-0.0072 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.2547 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.11973
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 20
|
-0.0037 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0989 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.13988
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 24
|
0.0203 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0698 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.18356
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 28
|
-0.0578 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0238 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.07607
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 32
|
-0.1571 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.2913 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 36
|
-0.0775 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0395 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.14069
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 40
|
-0.1208 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0357 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.07683
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 44
|
-0.0522 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0395 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.02754
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Eosinophils: Week 48
|
—
|
0.1645 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.10537
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 12
|
-0.2165 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.2552 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.57253
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 40
|
-0.2134 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.4961 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.05108
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 20
|
0.1325 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.3649 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.58710
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 28
|
0.0289 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.2517 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.50673
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 32
|
-1.1501 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.6357 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 36
|
0.0581 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.4619 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.00143
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 44
|
0.5638 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.4021 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.50620
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 48
|
—
|
-0.1701 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.33923
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Lymphocytes: Week 52
|
0.4700 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5256 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.60026
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 8
|
0.1094 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0230 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.15981
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 12
|
-0.0258 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0536 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.01924
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 16
|
-0.0289 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0148 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.00684
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 20
|
0.0132 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0307 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.11217
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 24
|
-0.0404 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0310 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.04098
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 28
|
0.0169 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0314 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.06868
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 32
|
-0.2902 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0410 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 40
|
-0.0708 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0884 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.20985
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 44
|
0.0601 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0110 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.02690
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 48
|
—
|
0.0492 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.04132
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Monocytes: Week 52
|
0.0164 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0112 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.01583
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 4
|
-0.1973 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.1626 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.16602
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 8
|
-3.5926 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.4712 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.43005
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 12
|
-0.1094 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.4876 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.20136
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 20
|
-0.8705 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0296 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.38241
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 28
|
1.6839 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.1160 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.33096
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 32
|
-5.3517 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.1306 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 40
|
-0.2730 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.0158 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.85667
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 44
|
0.5974 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0185 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.11095
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 48
|
—
|
0.3055 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.11948
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Neutrophils: Week 52
|
-0.0248 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.6728 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.91533
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 4
|
0.150 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.045 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.7849
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 8
|
-3.160 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.315 Giga cells per Liter (10^9 cells/L)
Standard Deviation 2.4254
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 12
|
-0.360 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.510 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.5798
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 16
|
-2.070 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.240 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.6505
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 20
|
-0.720 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.315 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.2516
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 24
|
-1.470 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.060 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.1879
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 28
|
1.690 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.385 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.0112
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 32
|
-6.970 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
2.130 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 36
|
1.140 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.070 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.8809
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 40
|
-0.680 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.605 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.9970
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 44
|
1.160 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.390 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.7212
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Leukocytes: Week 52
|
0.400 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.170 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.3253
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 4
|
16.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-30.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation 26.87
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 8
|
-31.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-41.5 Giga cells per Liter (10^9 cells/L)
Standard Deviation 34.65
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 12
|
-11.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-32.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation 39.60
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 16
|
-5.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-47.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation 14.14
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 20
|
5.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-39.5 Giga cells per Liter (10^9 cells/L)
Standard Deviation 27.58
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 24
|
-11.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-10.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation 7.07
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 28
|
10.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-14.5 Giga cells per Liter (10^9 cells/L)
Standard Deviation 6.36
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 36
|
-4.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-25.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.00
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 40
|
23.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-18.5 Giga cells per Liter (10^9 cells/L)
Standard Deviation 27.58
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 44
|
28.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-7.5 Giga cells per Liter (10^9 cells/L)
Standard Deviation 37.48
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 48
|
—
|
-36.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation 35.36
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count
Platelet count: Week 52
|
30.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
11.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation 65.05
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 44
|
5.60 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.20 Femtoliter (fL)
Standard Deviation 1.980
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 48
|
—
|
1.35 Femtoliter (fL)
Standard Deviation 0.778
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 52
|
3.40 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.45 Femtoliter (fL)
Standard Deviation 0.495
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 40
|
2.10 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.35 Femtoliter (fL)
Standard Deviation 1.626
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 32
|
0.80 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.90 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 36
|
1.00 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.25 Femtoliter (fL)
Standard Deviation 0.495
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 4
|
1.00 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.45 Femtoliter (fL)
Standard Deviation 0.919
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 28
|
2.60 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.70 Femtoliter (fL)
Standard Deviation 1.131
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 20
|
-0.20 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.85 Femtoliter (fL)
Standard Deviation 1.202
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 24
|
0.60 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.95 Femtoliter (fL)
Standard Deviation 1.202
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 8
|
2.10 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.35 Femtoliter (fL)
Standard Deviation 0.919
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 12
|
1.00 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
2.00 Femtoliter (fL)
Standard Deviation 1.414
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 16
|
3.10 Femtoliter (fL)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.15 Femtoliter (fL)
Standard Deviation 1.344
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 4
|
0.30 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.00 Picogram (pg)
Standard Deviation 0.849
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 8
|
0.20 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.45 Picogram (pg)
Standard Deviation 0.071
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 12
|
0.70 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.70 Picogram (pg)
Standard Deviation 0.141
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 20
|
0.90 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.85 Picogram (pg)
Standard Deviation 0.212
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 24
|
1.30 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.70 Picogram (pg)
Standard Deviation 0.000
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 28
|
1.20 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.45 Picogram (pg)
Standard Deviation 0.212
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 32
|
1.00 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.40 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 36
|
0.50 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.15 Picogram (pg)
Standard Deviation 0.636
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 40
|
1.60 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.55 Picogram (pg)
Standard Deviation 0.212
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 44
|
2.10 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.55 Picogram (pg)
Standard Deviation 1.061
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 48
|
—
|
0.80 Picogram (pg)
Standard Deviation 0.566
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 52
|
1.80 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.95 Picogram (pg)
Standard Deviation 1.626
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 16
|
1.30 Picogram (pg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.95 Picogram (pg)
Standard Deviation 0.212
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the clinical chemistry parameters: Calcium, Potassium, Sodium and BUN. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 16
|
0.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.5 millimoles per liter (mmol/L)
Standard Deviation 3.54
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 44
|
1.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5 millimoles per liter (mmol/L)
Standard Deviation 4.95
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 48
|
—
|
-1.0 millimoles per liter (mmol/L)
Standard Deviation 2.83
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 40
|
0.0000 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0624 millimoles per liter (mmol/L)
Standard Deviation 0.05293
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 52
|
0.0998 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.1747 millimoles per liter (mmol/L)
Standard Deviation 0.14114
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 44
|
0.20 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.40 millimoles per liter (mmol/L)
Standard Deviation 0.424
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 48
|
—
|
-0.25 millimoles per liter (mmol/L)
Standard Deviation 0.495
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 4
|
0.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.5 millimoles per liter (mmol/L)
Standard Deviation 3.54
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 32
|
0.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-3.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 8
|
-0.2142 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
2.1242 millimoles per liter (mmol/L)
Standard Deviation 4.06424
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 24
|
0.6069 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0000 millimoles per liter (mmol/L)
Standard Deviation 3.02925
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 44
|
2.2848 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.1603 millimoles per liter (mmol/L)
Standard Deviation 2.90303
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 8
|
0.30 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.40 millimoles per liter (mmol/L)
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 4
|
0.40 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.35 millimoles per liter (mmol/L)
Standard Deviation 0.354
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 12
|
0.40 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.30 millimoles per liter (mmol/L)
Standard Deviation 0.283
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 16
|
0.10 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.45 millimoles per liter (mmol/L)
Standard Deviation 0.212
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 20
|
0.30 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.10 millimoles per liter (mmol/L)
Standard Deviation 0.424
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 24
|
0.20 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.05 millimoles per liter (mmol/L)
Standard Deviation 0.495
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 28
|
0.30 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.55 millimoles per liter (mmol/L)
Standard Deviation 0.354
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 32
|
0.30 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.30 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 36
|
0.20 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.35 millimoles per liter (mmol/L)
Standard Deviation 0.071
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 40
|
0.40 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.55 millimoles per liter (mmol/L)
Standard Deviation 0.354
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Potassium: Week 52
|
0.50 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.20 millimoles per liter (mmol/L)
Standard Deviation 0.283
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 8
|
0.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5 millimoles per liter (mmol/L)
Standard Deviation 0.71
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 12
|
-1.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0 millimoles per liter (mmol/L)
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 20
|
1.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-2.0 millimoles per liter (mmol/L)
Standard Deviation 2.83
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 24
|
0.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.5 millimoles per liter (mmol/L)
Standard Deviation 2.12
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 28
|
-2.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5 millimoles per liter (mmol/L)
Standard Deviation 3.54
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 36
|
0.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5 millimoles per liter (mmol/L)
Standard Deviation 2.12
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 40
|
0.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-2.5 millimoles per liter (mmol/L)
Standard Deviation 3.54
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Sodium: Week 52
|
-1.0 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.5 millimoles per liter (mmol/L)
Standard Deviation 2.12
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 4
|
0.9996 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0893 millimoles per liter (mmol/L)
Standard Deviation 3.40790
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 12
|
1.7136 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.6962 millimoles per liter (mmol/L)
Standard Deviation 2.54961
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 16
|
1.3923 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.1964 millimoles per liter (mmol/L)
Standard Deviation 4.77106
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 20
|
0.7854 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.8390 millimoles per liter (mmol/L)
Standard Deviation 0.83304
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 28
|
3.6057 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0893 millimoles per liter (mmol/L)
Standard Deviation 2.90303
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 32
|
2.2134 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.4280 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 36
|
4.1055 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.4820 millimoles per liter (mmol/L)
Standard Deviation 1.33792
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 40
|
-0.6426 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
4.1948 millimoles per liter (mmol/L)
Standard Deviation 7.19446
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 48
|
—
|
0.4463 millimoles per liter (mmol/L)
Standard Deviation 2.90303
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
BUN: Week 52
|
1.9278 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.1424 millimoles per liter (mmol/L)
Standard Deviation 4.94777
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 4
|
0.0749 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.1123 millimoles per liter (mmol/L)
Standard Deviation 0.05293
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 8
|
-0.1248 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.1248 millimoles per liter (mmol/L)
Standard Deviation 0.10585
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 12
|
-0.0499 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.1372 millimoles per liter (mmol/L)
Standard Deviation 0.12350
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 16
|
0.0000 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.1372 millimoles per liter (mmol/L)
Standard Deviation 0.12350
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 20
|
0.0250 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0873 millimoles per liter (mmol/L)
Standard Deviation 0.08821
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 24
|
0.0250 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.0873 millimoles per liter (mmol/L)
Standard Deviation 0.15878
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 28
|
-0.0499 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.1871 millimoles per liter (mmol/L)
Standard Deviation 0.08821
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 32
|
0.0250 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0000 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 36
|
0.1248 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.1372 millimoles per liter (mmol/L)
Standard Deviation 0.12350
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 44
|
0.1248 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.1248 millimoles per liter (mmol/L)
Standard Deviation 0.07057
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Calcium: Week 48
|
—
|
-0.1123 millimoles per liter (mmol/L)
Standard Deviation 0.08821
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the clinical chemistry parameter: Creatinine. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 4
|
21.2160 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-3.0940 micromoles per Liter (µmol/L)
Standard Deviation 5.62574
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 8
|
139.6720 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.4420 micromoles per Liter (µmol/L)
Standard Deviation 9.37624
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 12
|
-1.7680 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
3.9780 micromoles per Liter (µmol/L)
Standard Deviation 10.62640
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 16
|
4.4200 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
14.5860 micromoles per Liter (µmol/L)
Standard Deviation 19.37755
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 20
|
-22.1000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
12.3760 micromoles per Liter (µmol/L)
Standard Deviation 6.25082
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 24
|
-5.3040 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
24.3100 micromoles per Liter (µmol/L)
Standard Deviation 26.87854
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 28
|
78.6760 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
13.7020 micromoles per Liter (µmol/L)
Standard Deviation 13.12673
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 32
|
83.9800 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
48.6200 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 36
|
95.4720 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
32.2660 micromoles per Liter (µmol/L)
Standard Deviation 45.63101
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 40
|
100.7760 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
65.4160 micromoles per Liter (µmol/L)
Standard Deviation 75.00989
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 44
|
115.8040 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
49.5040 micromoles per Liter (µmol/L)
Standard Deviation 57.50758
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 48
|
—
|
56.1340 micromoles per Liter (µmol/L)
Standard Deviation 65.63365
|
|
Change From Baseline in Clinical Chemistry Parameter: Creatinine
Week 52
|
151.1640 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
73.8140 micromoles per Liter (µmol/L)
Standard Deviation 94.38744
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the clinical chemistry parameters: ALT, ALP and AST. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST: Week 4
|
3.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1.0 International units per liter
Standard Deviation 1.41
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT: Week 4
|
2.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-2.0 International units per liter
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT: Week 8
|
2.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-2.5 International units per liter
Standard Deviation 0.71
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT: Week 12
|
2.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-3.5 International units per liter
Standard Deviation 0.71
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT: Week 24
|
0.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-3.5 International units per liter
Standard Deviation 2.12
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT: Week 32
|
1.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-5.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT: Week 36
|
-1.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1.0 International units per liter
Standard Deviation 0.00
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT: Week 40
|
-2.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-3.5 International units per liter
Standard Deviation 2.12
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT: Week 48
|
—
|
-0.5 International units per liter
Standard Deviation 4.95
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT: Week 52
|
0.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-4.5 International units per liter
Standard Deviation 0.71
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP: Week 4
|
34.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-29.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP: Week 8
|
13.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
77.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP: Week 12
|
31.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
123.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP: Week 24
|
36.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
23.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP: Week 32
|
29.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
141.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP: Week 36
|
14.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
113.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP: Week 40
|
2.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
100.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP: Week 48
|
—
|
35.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP: Week 52
|
2.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
46.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST: Week 8
|
5.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1.0 International units per liter
Standard Deviation 1.41
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST: Week 12
|
0.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-4.0 International units per liter
Standard Deviation 2.83
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST: Week 24
|
-1.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-5.5 International units per liter
Standard Deviation 3.54
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST: Week 32
|
1.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-4.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST: Week 36
|
-2.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-2.5 International units per liter
Standard Deviation 3.54
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST: Week 40
|
-3.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-4.0 International units per liter
Standard Deviation 4.24
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST: Week 48
|
—
|
-4.5 International units per liter
Standard Deviation 4.95
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST: Week 52
|
-2.0 International units per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-6.0 International units per liter
Standard Deviation 4.24
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the clinical chemistry parameters: Bilirubin and Direct Bilirubin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Bilirubin: Week 8
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.5390 micromoles per Liter (µmol/L)
Standard Deviation 2.17647
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Bilirubin: Week 36
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.9665 micromoles per Liter (µmol/L)
Standard Deviation 0.36275
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Direct Bilirubin: Week 52
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0855 micromoles per Liter (µmol/L)
Standard Deviation 0.12092
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Bilirubin: Week 40
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
3.5910 micromoles per Liter (µmol/L)
Standard Deviation 0.24183
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Bilirubin: Week 48
|
—
|
-0.3420 micromoles per Liter (µmol/L)
Standard Deviation 0.48366
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Bilirubin: Week 52
|
-1.7100 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.6245 micromoles per Liter (µmol/L)
Standard Deviation 2.29739
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Direct Bilirubin: Week 4
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation 0.00000
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Direct Bilirubin: Week 8
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.1710 micromoles per Liter (µmol/L)
Standard Deviation 0.24183
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Direct Bilirubin: Week 12
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.4275 micromoles per Liter (µmol/L)
Standard Deviation 0.60458
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Direct Bilirubin: Week 24
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.4275 micromoles per Liter (µmol/L)
Standard Deviation 0.60458
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Direct Bilirubin: Week 32
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Direct Bilirubin: Week 36
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0855 micromoles per Liter (µmol/L)
Standard Deviation 0.12092
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Direct Bilirubin: Week 40
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation 0.00000
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Direct Bilirubin: Week 48
|
—
|
0.0855 micromoles per Liter (µmol/L)
Standard Deviation 0.12092
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Bilirubin: Week 32
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
3.4200 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Bilirubin: Week 4
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.1115 micromoles per Liter (µmol/L)
Standard Deviation 1.57190
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Bilirubin: Week 12
|
0.0000 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
3.4200 micromoles per Liter (µmol/L)
Standard Deviation 4.83661
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin
Bilirubin: Week 24
|
-1.7100 micromoles per Liter (µmol/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
4.9590 micromoles per Liter (µmol/L)
Standard Deviation 2.17647
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the clinical chemistry parameter: Protein. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Protein
Week 4
|
6.00 Grams per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-2.30 Grams per liter
Standard Deviation 1.838
|
|
Change From Baseline in Clinical Chemistry Parameter: Protein
Week 8
|
5.00 Grams per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1.85 Grams per liter
Standard Deviation 1.202
|
|
Change From Baseline in Clinical Chemistry Parameter: Protein
Week 12
|
-1.00 Grams per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-2.65 Grams per liter
Standard Deviation 0.495
|
|
Change From Baseline in Clinical Chemistry Parameter: Protein
Week 24
|
2.00 Grams per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1.45 Grams per liter
Standard Deviation 2.051
|
|
Change From Baseline in Clinical Chemistry Parameter: Protein
Week 32
|
4.00 Grams per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
2.00 Grams per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameter: Protein
Week 36
|
6.00 Grams per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1.65 Grams per liter
Standard Deviation 3.748
|
|
Change From Baseline in Clinical Chemistry Parameter: Protein
Week 40
|
3.00 Grams per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
2.25 Grams per liter
Standard Deviation 5.303
|
|
Change From Baseline in Clinical Chemistry Parameter: Protein
Week 48
|
—
|
0.10 Grams per liter
Standard Deviation 2.687
|
|
Change From Baseline in Clinical Chemistry Parameter: Protein
Week 52
|
3.00 Grams per liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.65 Grams per liter
Standard Deviation 2.333
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the clinical chemistry parameter: Ferritin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 36
|
42.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-31.00 micrograms per liter (µg/L)
Standard Deviation 12.728
|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 4
|
-32.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-12.60 micrograms per liter (µg/L)
Standard Deviation 20.365
|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 8
|
167.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-17.30 micrograms per liter (µg/L)
Standard Deviation 12.304
|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 12
|
28.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-23.30 micrograms per liter (µg/L)
Standard Deviation 19.375
|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 16
|
-29.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-24.95 micrograms per liter (µg/L)
Standard Deviation 9.970
|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 20
|
-35.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-28.50 micrograms per liter (µg/L)
Standard Deviation 13.435
|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 24
|
-33.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-26.95 micrograms per liter (µg/L)
Standard Deviation 22.698
|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 28
|
-36.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-27.65 micrograms per liter (µg/L)
Standard Deviation 25.951
|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 32
|
-14.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-22.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 40
|
42.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-9.60 micrograms per liter (µg/L)
Standard Deviation 37.335
|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 44
|
75.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-3.00 micrograms per liter (µg/L)
Standard Deviation 59.397
|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 48
|
—
|
-16.30 micrograms per liter (µg/L)
Standard Deviation 50.487
|
|
Change From Baseline in Clinical Chemistry Parameter: Ferritin
Week 52
|
39.00 micrograms per liter (µg/L)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-5.05 micrograms per liter (µg/L)
Standard Deviation 56.498
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the clinical chemistry parameter: Transferrin saturation. Transferrin saturation is measured as a percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 28
|
-6.900 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-29.050 Percentage (%) of transferrin saturation
Standard Deviation 56.4978
|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 48
|
—
|
-25.715 Percentage (%) of transferrin saturation
Standard Deviation 28.6873
|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 52
|
-1.500 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-7.520 Percentage (%) of transferrin saturation
Standard Deviation 51.5905
|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 4
|
-6.900 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-14.990 Percentage (%) of transferrin saturation
Standard Deviation 43.8548
|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 8
|
-2.300 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
6.385 Percentage (%) of transferrin saturation
Standard Deviation 7.6155
|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 12
|
6.500 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-18.245 Percentage (%) of transferrin saturation
Standard Deviation 68.9500
|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 16
|
-0.900 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-2.775 Percentage (%) of transferrin saturation
Standard Deviation 4.5608
|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 20
|
-3.600 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-18.500 Percentage (%) of transferrin saturation
Standard Deviation 55.8614
|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 44
|
-7.600 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-27.305 Percentage (%) of transferrin saturation
Standard Deviation 27.8529
|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 24
|
-7.770 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-12.995 Percentage (%) of transferrin saturation
Standard Deviation 55.1614
|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 32
|
-8.100 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-69.000 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 36
|
3.100 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-31.620 Percentage (%) of transferrin saturation
Standard Deviation 62.7628
|
|
Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation
Week 40
|
3.100 Percentage (%) of transferrin saturation
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-32.230 Percentage (%) of transferrin saturation
Standard Deviation 52.0006
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the clinical chemistry parameter: Estimated Glomerular Filtration Rate. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 28
|
-0.930 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1.200 mL per minute per 1.73 square meter
Standard Deviation 1.2445
|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 32
|
-1.320 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-4.650 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 36
|
-1.460 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-2.370 mL per minute per 1.73 square meter
Standard Deviation 5.1053
|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 40
|
-1.580 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-6.565 mL per minute per 1.73 square meter
Standard Deviation 4.3346
|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 44
|
-1.770 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-4.855 mL per minute per 1.73 square meter
Standard Deviation 4.0800
|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 48
|
—
|
-5.410 mL per minute per 1.73 square meter
Standard Deviation 4.4548
|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 52
|
-2.260 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-5.935 mL per minute per 1.73 square meter
Standard Deviation 6.6539
|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 24
|
0.130 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-2.655 mL per minute per 1.73 square meter
Standard Deviation 2.3405
|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 4
|
-0.380 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.615 mL per minute per 1.73 square meter
Standard Deviation 0.7990
|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 8
|
-2.020 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.310 mL per minute per 1.73 square meter
Standard Deviation 2.4042
|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 12
|
0.040 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1.095 mL per minute per 1.73 square meter
Standard Deviation 3.0335
|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 16
|
-0.060 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1.530 mL per minute per 1.73 square meter
Standard Deviation 2.0365
|
|
Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate
Week 20
|
0.440 mL per minute per 1.73 square meter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1.740 mL per minute per 1.73 square meter
Standard Deviation 0.3253
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected to analyze the hematology parameter: Prothrombin International Normalized Ratio. It is used to assess the clotting ability of blood. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=1 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio
Week 52
|
0.030 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.040 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio
Week 4
|
-0.010 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.010 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio
Week 8
|
-0.040 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.050 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio
Week 12
|
0.010 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.030 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio
Week 24
|
-0.040 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.010 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio
Week 32
|
-0.010 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
—
|
|
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio
Week 36
|
0.010 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.020 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio
Week 40
|
0.030 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.010 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio
Week 48
|
—
|
-0.010 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Systolic and diastolic blood pressure (BP) were assessed using an appropriate size cuff preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 20
|
8.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-7.5 millimeters of mercury (mmHg)
Standard Deviation 9.19
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 12
|
-4.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 1.41
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 20
|
4.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-10.0 millimeters of mercury (mmHg)
Standard Deviation 9.90
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 28
|
6.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
4.0 millimeters of mercury (mmHg)
Standard Deviation 8.49
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 32
|
8.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
7.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 36
|
11.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
5.0 millimeters of mercury (mmHg)
Standard Deviation 4.24
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 40
|
2.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 5.66
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 2
|
11.5 millimeters of mercury (mmHg)
Standard Deviation 9.19
|
-8.0 millimeters of mercury (mmHg)
Standard Deviation 11.31
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 4
|
9.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
3.5 millimeters of mercury (mmHg)
Standard Deviation 7.78
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 8
|
6.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5 millimeters of mercury (mmHg)
Standard Deviation 16.26
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 12
|
0.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-9.5 millimeters of mercury (mmHg)
Standard Deviation 7.78
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 16
|
2.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-8.5 millimeters of mercury (mmHg)
Standard Deviation 2.12
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 24
|
25.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-7.0 millimeters of mercury (mmHg)
Standard Deviation 2.83
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 28
|
17.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 19.80
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 32
|
20.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
20.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 36
|
16.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
2.5 millimeters of mercury (mmHg)
Standard Deviation 14.85
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 40
|
10.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 28.28
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 44
|
7.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-5.5 millimeters of mercury (mmHg)
Standard Deviation 0.71
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 48
|
—
|
4.0 millimeters of mercury (mmHg)
Standard Deviation 29.70
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 52
|
4.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 16.97
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 2
|
3.5 millimeters of mercury (mmHg)
Standard Deviation 2.12
|
-7.5 millimeters of mercury (mmHg)
Standard Deviation 3.54
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 4
|
19.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
2.5 millimeters of mercury (mmHg)
Standard Deviation 14.85
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 8
|
8.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-3.0 millimeters of mercury (mmHg)
Standard Deviation 2.83
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 16
|
5.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-8.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 24
|
16.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-4.5 millimeters of mercury (mmHg)
Standard Deviation 10.61
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 44
|
11.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
4.5 millimeters of mercury (mmHg)
Standard Deviation 0.71
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 48
|
—
|
-2.0 millimeters of mercury (mmHg)
Standard Deviation 0.00
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 52
|
1.0 millimeters of mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-6.0 millimeters of mercury (mmHg)
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Heart rate (HR) were assessed using an appropriate size cuff preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Heart Rate (HR)
Week 36
|
1.00 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
3.5 beats per minute (bpm)
Standard Deviation 7.78
|
|
Change From Baseline in Heart Rate (HR)
Week 2
|
-12.5 beats per minute (bpm)
Standard Deviation 9.19
|
-9.0 beats per minute (bpm)
Standard Deviation 4.24
|
|
Change From Baseline in Heart Rate (HR)
Week 4
|
2.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-2.0 beats per minute (bpm)
Standard Deviation 18.38
|
|
Change From Baseline in Heart Rate (HR)
Week 8
|
15.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-8.0 beats per minute (bpm)
Standard Deviation 28.28
|
|
Change From Baseline in Heart Rate (HR)
Week 12
|
5.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-11.0 beats per minute (bpm)
Standard Deviation 43.84
|
|
Change From Baseline in Heart Rate (HR)
Week 16
|
-10.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-12.0 beats per minute (bpm)
Standard Deviation 14.14
|
|
Change From Baseline in Heart Rate (HR)
Week 20
|
0.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
4.0 beats per minute (bpm)
Standard Deviation 14.14
|
|
Change From Baseline in Heart Rate (HR)
Week 24
|
8.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
5.5 beats per minute (bpm)
Standard Deviation 6.36
|
|
Change From Baseline in Heart Rate (HR)
Week 28
|
14.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
3.0 beats per minute (bpm)
Standard Deviation 5.66
|
|
Change From Baseline in Heart Rate (HR)
Week 32
|
11.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-12.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Heart Rate (HR)
Week 40
|
-1.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
30.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Heart Rate (HR)
Week 44
|
12.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-3.5 beats per minute (bpm)
Standard Deviation 12.02
|
|
Change From Baseline in Heart Rate (HR)
Week 48
|
—
|
-17.5 beats per minute (bpm)
Standard Deviation 14.85
|
|
Change From Baseline in Heart Rate (HR)
Week 52
|
-3.0 beats per minute (bpm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
3.0 beats per minute (bpm)
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Weight readings in kilogram (kg) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Weight
Week 24
|
2.00 kilograms (Kg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.45 kilograms (Kg)
Standard Deviation 0.212
|
|
Change From Baseline in Weight
Week 28
|
1.70 kilograms (Kg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.80 kilograms (Kg)
Standard Deviation 0.990
|
|
Change From Baseline in Weight
Week 32
|
1.00 kilograms (Kg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.90 kilograms (Kg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Weight
Week 36
|
0.20 kilograms (Kg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.95 kilograms (Kg)
Standard Deviation 1.768
|
|
Change From Baseline in Weight
Week 40
|
0.80 kilograms (Kg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.95 kilograms (Kg)
Standard Deviation 1.061
|
|
Change From Baseline in Weight
Week 44
|
1.50 kilograms (Kg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.85 kilograms (Kg)
Standard Deviation 0.495
|
|
Change From Baseline in Weight
Week 48
|
—
|
2.90 kilograms (Kg)
Standard Deviation 0.000
|
|
Change From Baseline in Weight
Week 52
|
1.30 kilograms (Kg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
2.70 kilograms (Kg)
Standard Deviation 0.000
|
|
Change From Baseline in Weight
Week 8
|
-2.40 kilograms (Kg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.40 kilograms (Kg)
Standard Deviation 0.141
|
|
Change From Baseline in Weight
Week 16
|
-0.50 kilograms (Kg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.60 kilograms (Kg)
Standard Deviation 0.283
|
|
Change From Baseline in Weight
Week 20
|
2.20 kilograms (Kg)
|
0.70 kilograms (Kg)
Standard Deviation 0.849
|
|
Change From Baseline in Weight
Week 12
|
1.20 kilograms (Kg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.00 kilograms (Kg)
Standard Deviation 0.566
|
|
Change From Baseline in Weight
Week 4
|
-1.80 kilograms (Kg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.25 kilograms (Kg)
Standard Deviation 1.485
|
|
Change From Baseline in Weight
Week 2
|
-1.00 kilograms (Kg)
Standard Deviation 0.141
|
-0.70 kilograms (Kg)
Standard Deviation 0.566
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Height readings in centimeters (cm) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Height
Week 32
|
0.80 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
5.30 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change From Baseline in Height
Week 36
|
0.50 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
5.00 centimeters (cm)
Standard Deviation 1.131
|
|
Change From Baseline in Height
Week 40
|
0.20 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
4.50 centimeters (cm)
Standard Deviation 2.546
|
|
Change From Baseline in Height
Week 44
|
0.20 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
5.65 centimeters (cm)
Standard Deviation 2.192
|
|
Change From Baseline in Height
Week 48
|
—
|
5.65 centimeters (cm)
Standard Deviation 2.192
|
|
Change From Baseline in Height
Week 52
|
-0.70 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
6.25 centimeters (cm)
Standard Deviation 2.333
|
|
Change From Baseline in Height
Week 2
|
-1.50 centimeters (cm)
Standard Deviation 2.121
|
0.85 centimeters (cm)
Standard Deviation 1.202
|
|
Change From Baseline in Height
Week 4
|
0.00 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.95 centimeters (cm)
Standard Deviation 0.495
|
|
Change From Baseline in Height
Week 8
|
0.00 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.20 centimeters (cm)
Standard Deviation 0.707
|
|
Change From Baseline in Height
Week 12
|
0.00 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
2.65 centimeters (cm)
Standard Deviation 0.071
|
|
Change From Baseline in Height
Week 16
|
0.10 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.85 centimeters (cm)
Standard Deviation 1.485
|
|
Change From Baseline in Height
Week 20
|
0.30 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
3.35 centimeters (cm)
Standard Deviation 0.495
|
|
Change From Baseline in Height
Week 24
|
0.30 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
3.70 centimeters (cm)
Standard Deviation 0.707
|
|
Change From Baseline in Height
Week 28
|
1.00 centimeters (cm)
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
4.60 centimeters (cm)
Standard Deviation 0.141
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected from all participants for measurement of Hgb values in grams per deciliter (g/dL). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Hgb results of participants with intercurrent events were excluded from the summary.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Absolute Values of Hemoglobin (Hgb)
Baseline (Day 1)
|
11.00 grams per deciliter
Standard Deviation 0.424
|
11.35 grams per deciliter
Standard Deviation 0.919
|
|
Absolute Values of Hemoglobin (Hgb)
Week 2
|
10.85 grams per deciliter
Standard Deviation 1.061
|
11.90 grams per deciliter
Standard Deviation 0.990
|
|
Absolute Values of Hemoglobin (Hgb)
Week 4
|
11.80 grams per deciliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
11.50 grams per deciliter
Standard Deviation 0.566
|
|
Absolute Values of Hemoglobin (Hgb)
Week 8
|
—
|
11.65 grams per deciliter
Standard Deviation 0.212
|
|
Absolute Values of Hemoglobin (Hgb)
Week 12
|
—
|
11.80 grams per deciliter
Standard Deviation 0.283
|
|
Absolute Values of Hemoglobin (Hgb)
Week 16
|
—
|
10.95 grams per deciliter
Standard Deviation 0.495
|
|
Absolute Values of Hemoglobin (Hgb)
Week 20
|
—
|
11.55 grams per deciliter
Standard Deviation 0.212
|
|
Absolute Values of Hemoglobin (Hgb)
Week 24
|
—
|
11.70 grams per deciliter
Standard Deviation 0.141
|
|
Absolute Values of Hemoglobin (Hgb)
Week 28
|
—
|
11.65 grams per deciliter
Standard Deviation 0.354
|
|
Absolute Values of Hemoglobin (Hgb)
Week 32
|
—
|
11.80 grams per deciliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Absolute Values of Hemoglobin (Hgb)
Week 36
|
—
|
11.95 grams per deciliter
Standard Deviation 0.354
|
|
Absolute Values of Hemoglobin (Hgb)
Week 40
|
—
|
12.10 grams per deciliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Absolute Values of Hemoglobin (Hgb)
Week 44
|
—
|
11.20 grams per deciliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Absolute Values of Hemoglobin (Hgb)
Week 48
|
—
|
11.90 grams per deciliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Absolute Values of Hemoglobin (Hgb)
Week 52
|
—
|
12.60 grams per deciliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected from all participants for measurement of Hgb values in g/dL. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Hgb results of participants with intercurrent events were excluded from the summary.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change From Baseline in Hemoglobin (Hgb)
Week 2
|
-0.15 grams per Liter
Standard Deviation 0.636
|
0.55 grams per Liter
Standard Deviation 0.071
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 4
|
0.5 grams per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant.
|
0.15 grams per Liter
Standard Deviation 1.485
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 8
|
—
|
0.30 grams per Liter
Standard Deviation 1.131
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 12
|
—
|
0.45 grams per Liter
Standard Deviation 0.636
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 16
|
—
|
-0.40 grams per Liter
Standard Deviation 1.414
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 20
|
—
|
0.20 grams per Liter
Standard Deviation 0.707
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 24
|
—
|
0.35 grams per Liter
Standard Deviation 1.061
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 28
|
—
|
0.30 grams per Liter
Standard Deviation 1.273
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 32
|
—
|
1.10 grams per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant.
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 36
|
—
|
0.60 grams per Liter
Standard Deviation 0.566
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 40
|
—
|
0.10 grams per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant.
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 44
|
—
|
-0.80 grams per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant.
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 48
|
—
|
-0.10 grams per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant.
|
|
Change From Baseline in Hemoglobin (Hgb)
Week 52
|
—
|
0.60 grams per Liter
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant.
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Number of participants with Hgb values above, below, and within the target range (10 to 12 g/dL) were assessed. Baseline assessment was defined as the last non-missing value prior to the start date and time of the study drug (Day 1). Hgb results of participants with intercurrent events were excluded from the summary.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 4 · Within Target Range
|
1 Participants
|
2 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 4 · Below Target Range
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 8 · Above Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 8 · Within Target Range
|
—
|
2 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 8 · Below Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 12 · Above Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 12 · Within Target Range
|
—
|
2 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 16 · Above Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 16 · Within Target Range
|
—
|
2 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 16 · Below Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 20 · Above Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 20 · Within Target Range
|
—
|
2 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 20 · Below Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 24 · Above Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 24 · Within Target Range
|
—
|
2 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 24 · Below Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 28 · Above Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 28 · Within Target Range
|
—
|
2 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 28 · Below Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 32 · Above Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 32 · Within Target Range
|
—
|
1 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 32 · Below Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 36 · Within Target Range
|
—
|
1 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 36 · Below Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 40 · Above Target Range
|
—
|
1 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 40 · Within Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 40 · Below Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 44 · Within Target Range
|
—
|
1 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 44 · Below Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 48 · Above Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 48 · Below Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 52 · Above Target Range
|
—
|
1 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 52 · Within Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 52 · Below Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Baseline (Day 1) · Above Target Range
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 2 · Above Target Range
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 12 · Below Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 36 · Above Target Range
|
—
|
1 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 44 · Above Target Range
|
—
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 48 · Within Target Range
|
—
|
1 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Baseline (Day 1) · Within Target Range
|
2 Participants
|
2 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Baseline (Day 1) · Below Target Range
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 2 · Within Target Range
|
2 Participants
|
1 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 2 · Below Target Range
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)
Week 4 · Above Target Range
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Daprodustat dose was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for Hgb between 10 to 12 g/dL. Dose change values of daprodustat from starting dose at each study time point were calculated as dose level at indicated time point minus starting dose at Day 1 (Baseline).
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 12
|
-2 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5 milligrams
Standard Deviation 0.71
|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 16
|
0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5 milligrams
Standard Deviation 0.71
|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 32
|
-6 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 36
|
-4 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1 milligrams
Standard Deviation 1.41
|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 44
|
-4 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-1 milligrams
Standard Deviation 0
|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 48
|
—
|
-1 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 2
|
0 milligrams
Standard Deviation 0
|
-1 milligrams
Standard Deviation 1.41
|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 4
|
0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5 milligrams
Standard Deviation 0.71
|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 8
|
-6 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5 milligrams
Standard Deviation 0.71
|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 20
|
0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5 milligrams
Standard Deviation 0.71
|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 24
|
0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5 milligrams
Standard Deviation 0.71
|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 28
|
-2 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-0.5 milligrams
Standard Deviation 0.71
|
|
Change in Daprodustat Dose From Starting Dose at Each Study Time Point
Week 40
|
-4 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
-2 milligrams
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Safety Set
Number of participants who required daprodustat dose adjustments form the starting dose were assessed. Data were categorized for number of participants who required no dose change (0 times) to 10 times and \>10 times dose adjustments during the study.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
No dose change (0 time)
|
1 Participants
|
0 Participants
|
|
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
1 time
|
0 Participants
|
0 Participants
|
|
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
2 times
|
0 Participants
|
1 Participants
|
|
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
3 times
|
0 Participants
|
0 Participants
|
|
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
5 times
|
0 Participants
|
0 Participants
|
|
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
6 times
|
1 Participants
|
1 Participants
|
|
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
9 times
|
0 Participants
|
0 Participants
|
|
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
10 times
|
0 Participants
|
0 Participants
|
|
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
>10 times
|
0 Participants
|
0 Participants
|
|
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
4 times
|
0 Participants
|
0 Participants
|
|
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
7 times
|
0 Participants
|
0 Participants
|
|
Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments
8 times
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48Population: Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Mean and standard deviation of daprodustat dose received by participants at each study time point has been presented.
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Daprodustat Dose at Each Study Time Point
Week 20
|
6.0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.5 milligrams
Standard Deviation 0.71
|
|
Daprodustat Dose at Each Study Time Point
Week 40
|
2.0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
0.0 milligrams
Standard Deviation 0.00
|
|
Daprodustat Dose at Each Study Time Point
Baseline (Day 1)
|
6.0 milligrams
Standard Deviation 0.00
|
2.0 milligrams
Standard Deviation 0.00
|
|
Daprodustat Dose at Each Study Time Point
Week 2
|
6.0 milligrams
Standard Deviation 0.00
|
1.0 milligrams
Standard Deviation 1.41
|
|
Daprodustat Dose at Each Study Time Point
Week 4
|
6.0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.5 milligrams
Standard Deviation 0.71
|
|
Daprodustat Dose at Each Study Time Point
Week 8
|
0.0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.5 milligrams
Standard Deviation 0.71
|
|
Daprodustat Dose at Each Study Time Point
Week 12
|
4.0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.5 milligrams
Standard Deviation 0.71
|
|
Daprodustat Dose at Each Study Time Point
Week 16
|
6.0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.5 milligrams
Standard Deviation 0.71
|
|
Daprodustat Dose at Each Study Time Point
Week 24
|
6.00 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.5 milligrams
Standard Deviation 0.71
|
|
Daprodustat Dose at Each Study Time Point
Week 28
|
4.0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.5 milligrams
Standard Deviation 0.71
|
|
Daprodustat Dose at Each Study Time Point
Week 32
|
0.0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
2.0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
|
Daprodustat Dose at Each Study Time Point
Week 36
|
2.0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.0 milligrams
Standard Deviation 1.41
|
|
Daprodustat Dose at Each Study Time Point
Week 44
|
2.0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
1.0 milligrams
Standard Deviation 0.00
|
|
Daprodustat Dose at Each Study Time Point
Week 48
|
—
|
1.0 milligrams
Standard Deviation NA
NA indicates that standard deviation could not be calculated for single participant
|
SECONDARY outcome
Timeframe: Day 1: 1, 2 and 6 hours Post-dose; Week 2: Pre-dose and 1, 2 and 6 hours Post-dosePopulation: The analysis was performed on the All Pharmacokinetic Set that included all participants in the Safety analysis who had at least 1 non-missing PK assessment (non-quantifiable values will be considered as non-missing values).
Blood samples were collected for the plasma concentrations of daprodustat from which pharmacokinetic (PK) parameters were determined. Mean and standard deviation of daprodustat Cmax at steady state obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis).
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Daprodustat
|
115.047 Nanograms per milliliters (ng/mL)
Standard Deviation 3.854
|
19.447 Nanograms per milliliters (ng/mL)
Standard Deviation 10.770
|
SECONDARY outcome
Timeframe: Day 1: 1, 2 and 6 hours Post-dose; Week 2: Pre-dose and 1, 2 and 6 hours Post-dosePopulation: All Pharmacokinetic Set
Blood samples were collected for the plasma concentrations of daprodustat from which PK parameters were determined. Mean and standard deviation of daprodustat AUC at steady state obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis).
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Area Under the Curve (AUC) at Steady State of Daprodustat
|
185.379 Hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 8.661
|
56.634 Hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 6.009
|
SECONDARY outcome
Timeframe: Pre-dose on Week 2Population: All Pharmacokinetic Set
Blood samples were collected for the plasma concentrations of daprodustat and metabolites from which PK parameters were determined. Mean and standard deviation of raw daprodustat and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401) at steady state at pre-dose obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis).
Outcome measures
| Measure |
Participants Requiring Dialysis (D)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 Participants
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough)
Daprodustat
|
0.4995 Nanograms per milliliters (ng/mL)
Standard Deviation 0.3698
|
NA Nanograms per milliliters (ng/mL)
Standard Deviation NA
Data could not be calculated as the concentration values were below the lower limit of quantification
|
|
Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough)
GSK2391220
|
6.540 Nanograms per milliliters (ng/mL)
Standard Deviation 2.206
|
NA Nanograms per milliliters (ng/mL)
Standard Deviation NA
Data could not be calculated as the concentration values were below the lower limit of quantification
|
|
Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough)
GSK2487818
|
0.869 Nanograms per milliliters (ng/mL)
Standard Deviation 0.137
|
NA Nanograms per milliliters (ng/mL)
Standard Deviation NA
Data could not be calculated as the concentration values were below the lower limit of quantification
|
|
Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough)
GSK2506102
|
3.040 Nanograms per milliliters (ng/mL)
Standard Deviation 0.424
|
NA Nanograms per milliliters (ng/mL)
Standard Deviation NA
Data could not be calculated as the concentration values were below the lower limit of quantification
|
|
Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough)
GSK2506104
|
10.55 Nanograms per milliliters (ng/mL)
Standard Deviation 3.18
|
0.143 Nanograms per milliliters (ng/mL)
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed
|
|
Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough)
GSK2531398
|
2.490 Nanograms per milliliters (ng/mL)
Standard Deviation 0.184
|
NA Nanograms per milliliters (ng/mL)
Standard Deviation NA
Data could not be calculated as the concentration values were below the lower limit of quantification
|
|
Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough)
GSK2531401
|
11.25 Nanograms per milliliters (ng/mL)
Standard Deviation 1.48
|
0.127 Nanograms per milliliters (ng/mL)
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed
|
Adverse Events
Participants Requiring Dialysis (D)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Participants Not Yet Requiring Dialysis (ND)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants Requiring Dialysis (D)
n=2 participants at risk
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 participants at risk
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Congenital, familial and genetic disorders
Congenital uterine anomaly
|
50.0%
1/2 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
50.0%
1/2 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
Other adverse events
| Measure |
Participants Requiring Dialysis (D)
n=2 participants at risk
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
Participants Not Yet Requiring Dialysis (ND)
n=2 participants at risk
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
50.0%
1/2 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
|
Investigations
Serum ferritin increased
|
50.0%
1/2 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
|
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