Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants |
The mean hemoglobin during the primary efficacy evaluation period in ND participants was estimated by a statistical model using Mixed Model Repeated Measures (MMRM). |
Weeks 40 to 52 |
|
Secondary |
Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) |
ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period were summarized. Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period. |
Weeks 40 to 52 |
|
Secondary |
Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) |
The percentage of ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period. |
Weeks 40 to 52 |
|
Secondary |
Change From Baseline in Hgb at Week 4 in ND Participants |
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb at Week 4 in ND participants is presented. |
Baseline (Day 1) and Week 4 |
|
Secondary |
Change From Baseline in Hgb at Week 4 in PD Participants |
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb at week 4 in PD participants is presented. |
Baseline (Day 1) and Week 4 |
|
Secondary |
Number of ND Participants by Hgb Change From Baseline Category at Week 4 |
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to <=-2.0, >-2.0 and <=-1.0, >-1.0 and <=0, >0 and <=1.0, >1.0 and <=2.0, >2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4. |
Baseline (Day 1) and Week 4 |
|
Secondary |
Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 |
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to <=-2.0, >-2.0 and <=-1.0, >-1.0 and <=0, >0 and <=1.0, >1.0 and <=2.0, >2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4. |
Baseline (Day 1) and Week 4 |
|
Secondary |
Number of PD Participants by Hgb Change From Baseline Category at Week 4 |
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to <=-2.0, >-2.0 and <=-1.0, >-1.0 and <=0, >0 and <=1.0, >1.0 and <=2.0, >2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4. |
Baseline (Day 1) and Week 4 |
|
Secondary |
Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 |
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to <=-2.0, >-2.0 and <=-1.0, >-1.0 and <=0, >0 and <=1.0, >1.0 and <=2.0, >2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4. |
Baseline (Day 1) and Week 4 |
|
Secondary |
Daprodustat Dose Level by Visit in ND Participants |
Daprodustat dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75). |
Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48 |
|
Secondary |
Epoetin Beta Pegol Dose Level by Visit in ND Participants |
Dose of epoetin beta pegol at a scheduled visit was converted to dose per 4 weeks when the dose frequency was every 2 weeks. Epoetin beta pegol dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75). |
Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48 |
|
Secondary |
Daprodustat Dose Level by Visit in PD Participants |
Daprodustat dose level at each assessment visit for PD participants is presented using 25th percentile (P25), median, and 75th percentile (P75). |
Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48 |
|
Secondary |
Duration of Treatment Interruption Due to Hgb >13 g/dL in ND Participants |
The duration (in days) of treatment interruption due to Hgb >13 g/dL per participant was summarized descriptively on participants with a period of treatment interruption due to Hgb >13 g/dL. |
Up to Week 52 |
|
Secondary |
Duration of Treatment Interruption Due to Hgb >13 g/dL in PD Participants |
The duration (in days) of treatment interruption due to Hgb >13 g/dL per participant was summarized descriptively on participants with a period of treatment interruption due to Hgb >13 g/dL. |
Up to Week 52 |
|
Secondary |
Number of Dose Adjustments in ND Participants |
Number of dose adjustments in ND participants is presented. |
Up to Week 52 |
|
Secondary |
Number of Dose Adjustments in PD Participants |
Number of dose adjustments in PD participants is presented. |
Up to Week 52 |
|
Secondary |
Hgb Values at Each Assessment Visit in ND Participants |
Hgb values at each assessment visit for ND participants is presented. |
Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 |
|
Secondary |
Hgb Values at Each Assessment Visit in PD Participants |
Hgb values at each assessment visit for PD participants is presented. |
Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 |
|
Secondary |
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants |
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb values at each assessment visit in ND participants is presented. |
Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 |
|
Secondary |
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants |
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb values at each assessment visit in PD participants is presented. |
Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 |
|
Secondary |
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit |
Number of ND participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit. |
Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 |
|
Secondary |
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit |
Percentage of ND participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit. |
Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 |
|
Secondary |
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit |
Number of PD participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit. |
Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 |
|
Secondary |
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit |
Percentage of PD participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit. |
Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 |
|
Secondary |
Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants |
Mean percentage of time with Hgb within the target range (11.0 to 13.0 g/dL) is summarized during the primary efficacy evaluation period (Weeks 40 to 52). |
Weeks 40 to 52 |
|
Secondary |
Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in PD Participants |
Mean percentage of time with Hgb within the target range (11.0 to 13.0 g/dL) is summarized during the primary efficacy evaluation period (Weeks 40 to 52). |
Weeks 40 to 52 |
|
Secondary |
Time to Reach the Lower Target Hgb Level (11.0 g/dL) in ND Participants |
The time (in days) to reach the lower target Hgb level (11.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method. Participants who did not reach the lower Hgb target were considered as censored cases. Participants who were randomized as Hgb >= 11.0 g/dL were excluded in this summary. |
Up to week 52 |
|
Secondary |
Time to Reach the Lower Target Hgb Level (11.0 g/dL) in PD Participants |
The time (in days) to reach the lower target Hgb level (11.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method. Participants who did not reach the lower Hgb target were considered as censored cases. Participants who were randomized as Hgb >= 11.0 g/dL were excluded in this summary. |
Up to week 52 |
|
Secondary |
Number of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL |
Number of ND participants who had an Hgb level of less than 7.5 g/dL is presented. |
Up to week 52 |
|
Secondary |
Percentage of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL |
Percentage of ND participants who had an Hgb level of less than 7.5 g/dL is presented. |
Up to week 52 |
|
Secondary |
Number of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL |
Number of PD participants who had an Hgb level of less than 7.5 g/dL is presented. |
Up to week 52 |
|
Secondary |
Percentage of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL |
Percentage of PD participants who had an Hgb level of less than 7.5 g/dL is presented. |
Up to week 52 |
|
Secondary |
Number of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks |
Number of ND participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented. |
Up to week 52 |
|
Secondary |
Percentage of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks |
Percentage of ND participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented. |
Up to week 52 |
|
Secondary |
Number of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks |
Number of PD participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented. |
Up to week 52 |
|
Secondary |
Percentage of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks |
Percentage of PD participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented. |
Up to week 52 |
|
Secondary |
Number of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL |
Number of ND participants who had an Hgb level of more than 13.0 g/dL is presented. |
Up to week 52 |
|
Secondary |
Percentage of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL |
Percentage of ND participants who had an Hgb level of more than 13.0 g/dL is presented. |
Up to week 52 |
|
Secondary |
Number of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL |
Number of PD participants who had an Hgb level of more than 13.0 g/dL is presented. |
Up to week 52 |
|
Secondary |
Percentage of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL |
Percentage of PD participants who had an Hgb level of more than 13.0 g/dL is presented. |
Up to week 52 |
|
Secondary |
Number of Episodes With Hgb Level of More Than 13.0 g/dL in ND Participants |
Number of episodes with Hgb level of more than 13.0 g/dL in ND participants is presented. |
Up to week 52 |
|
Secondary |
Number of Episodes With Hgb Level of More Than 13.0 g/dL in PD Participants |
Number of episodes with Hgb level of more than 13.0 g/dL in PD participants is presented. |
Up to week 52 |
|
Secondary |
Monthly Average Dose of Oral Iron During the Treatment Period in ND Participants |
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron = Total oral iron dose (mg) / (duration in days / 30.4375 days). Monthly average dose of oral iron during the treatment period in ND participants is presented. |
Up to Week 52 |
|
Secondary |
Monthly Average Dose of Oral Iron During the Treatment Period in PD Participants |
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron = Total oral iron dose (mg) / (duration in days / 30.4375 days). Monthly average dose of oral iron during the treatment period in PD participants is presented. |
Up to Week 52 |
|
Secondary |
Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in ND Participants |
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron dose during the primary efficacy evaluation period (Weeks 40 to 52) = Total oral iron dose (mg) during the primary efficacy evaluation period / (duration in the period in days / 30.4375 days). Monthly average dose of oral iron during the primary efficacy evaluation period in ND participants is presented. |
Weeks 40 to 52 |
|
Secondary |
Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in PD Participants |
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron dose during the primary efficacy evaluation period (Weeks 40 to 52) = Total oral iron dose (mg) during the primary efficacy evaluation period / (duration in the period in days / 30.4375 days). Monthly average dose of oral iron during the primary efficacy evaluation period in PD participants is presented. |
Weeks 40 to 52 |
|
Secondary |
Number of ND Participants Who Used Oral Iron During the Treatment Period |
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of ND participants who used oral iron during the treatment period were summarized. |
Up to week 52 |
|
Secondary |
Number of PD Participants Who Used Oral Iron During the Treatment Period |
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of PD participants who used oral iron during the treatment period were summarized. |
Up to week 52 |
|
Secondary |
Percentage of ND Participants Who Used Oral Iron During the Treatment Period |
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of ND participants who used oral iron during the treatment period were summarized. |
Up to week 52 |
|
Secondary |
Percentage of PD Participants Who Used Oral Iron During the Treatment Period |
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of PD participants who used oral iron during the treatment period were summarized. |
Up to week 52 |
|
Secondary |
Number of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period |
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of ND participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized. |
Weeks 40 to 52 |
|
Secondary |
Number of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period |
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of PD participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized. |
Weeks 40 to 52 |
|
Secondary |
Percentage of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period |
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of ND participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized. |
Weeks 40 to 52 |
|
Secondary |
Percentage of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period |
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of PD participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized. |
Weeks 40 to 52 |
|
Secondary |
Change From Baseline in Ferritin in ND Participants |
Change from Baseline in Ferritin in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Ferritin is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction. |
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 |
|
Secondary |
Change From Baseline in Ferritin in PD Participants |
Change from Baseline in Ferritin in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Ferritin is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction. |
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 |
|
Secondary |
Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants |
Percent change from Baseline in TSAT in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in TSAT is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction. |
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 |
|
Secondary |
Percent Change From Baseline in TSAT in PD Participants |
Percent change from Baseline in TSAT in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in TSAT is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction. |
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 |
|
Secondary |
Percent Change From Baseline in Hepcidin in ND Participants |
Percent change from Baseline in Hepcidin in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in Hepcidin is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction. |
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 |
|
Secondary |
Percent Change From Baseline in Hepcidin in PD Participants |
Percent change from Baseline in Hepcidin in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in Hepcidin is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction. |
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 |
|
Secondary |
Change From Baseline in Serum Iron in ND Participants |
Change from Baseline in serum iron in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Serum iron is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction. |
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 |
|
Secondary |
Change From Baseline in Serum Iron in PD Participants |
Change from Baseline in serum iron in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Serum iron is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction. |
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 |
|
Secondary |
Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants |
Change from Baseline in TIBC in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in TIBC is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction. |
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 |
|
Secondary |
Change From Baseline in TIBC in PD Participants |
Change from Baseline in TIBC in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in TIBC is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction. |
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52 |
|
Secondary |
Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants |
Blood samples were collected at indicated timepoints. Pharmacokinetic (PK) parameters of Daprodustat were calculated using non-compartmental method. AUC (0-4) is presented for combined Week 12 and 24. Geometric mean and geometric coefficient of variation is presented. NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant. |
1, 2, 3 and 4 hours post dose at Weeks 12 and 24 |
|
Secondary |
Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants |
Blood samples were collected at indicated timepoints. PK parameters of Daprodustat were calculated using non-compartmental method. Cmax is presented for combined Week 12 and 24. Geometric mean and geometric coefficient of variation is presented. NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant. |
1, 2, 3 and 4 hours post dose at Weeks 12 and 24 |
|