Trial · NCT02969655
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | The mean hemoglobin during the Evaluation Period was estimated by a statistical model. |
| Secondary | Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | The percentage of participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Odds ratio was estimated using a logistic regression and provided along with its 95% CI and a one-sided p-value. |
| Secondary | Change From Baseline in Hgb (Hgb Increase Rate) at Week 4 | Baseline and Week 4 | Change from Baseline was calculated as the post-dose Week 4 visit value minus the Baseline value. |
| Secondary | Percentage of Participants by Hgb Change From Baseline Category at Week 4 | Week 4 | Percentage of participants within each category were provided only for daprodustat and the categories were classified into 6 (i.e., \<=-2, \>-2 to -1, \>-1 to 0, \>0 to 1, \>1 to 2, \>2 grams per deciliter \[g/dL\]). In addition, 'within 1.0 g/dL (i.e., \<=-1 and \>=1) and over 2.0 g/dL (i.e., \<-2 and \>2) categories were provided. |
| Secondary | Distribution of Daprodustat Dose Level by Visit | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44, and 48) | Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Daprodustat. Median along with the interquartile range (25th and 75th percentile) has been presented. |
| Secondary | Distribution of Darbepoetin Alfa Dose Level by Visit | Day 1, Weeks 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48, and 50 | Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Darbepoetin Alfa. Median along with the interquartile range (25th and 75th percentile) has been presented. |
| Secondary | Duration of Treatment Interruption Due to Hgb >13 g/dL | Up to Week 52 | Duration of treatment interruption due to Hgb \>13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for the daprodustat group. |
| Secondary | Number of Dose Adjustments for Daprodustat | Up to Week 52 | Number of dose adjustments has been presented only for daprodustat. |
| Secondary | Hgb Values at Each Assessment Visit | Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented. |
| Secondary | Change From Baseline in Hgb Values at Each Assessment Visit | Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calcuated as the post-dose visit value minus the Baseline value. Change from Baseline Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented. |
| Secondary | Percentage of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) at Each Assessment Visit | Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Percentage of participants with Hgb within the target range was summarized at each assessment visit by treatment group have been presented. |
| Secondary | Percentage of Time in Hgb Target Range (10.0 to 12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | Percentage of time in Hgb target range (10.0 to 12.0 g/dL) during the primary efficacy evaluation period (Weeks 40 to 52) for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented. |
| Secondary | Number of Participants Who Had an Hgb Level of Less Than 7.5 g/dL | Up to Week 52 | If an initial Hgb value was less than 7.5 g/dL, measurement was repeated at the same study visit (using the same sample) to calculate the average. If the average met the Hgb stopping criteria, study treatment was permanently discontinued. Number of participants who had an Hgb level of less than 7.5 g/dL has been presented. |
| Secondary | Number of Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | Up to Week 52 | Number of participants who had an Hgb increase of more than 2 g/dL over any 4 weeks for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented. |
| Secondary | Number of Participants Who Had an Hgb Level of More Than 13.0 g/dL | Up to Week 52 | Number of participants who had an Hgb increase of more than 13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented. |
| Secondary | Number of Episodes With Hgb Level of More Than 13.0 g/dL | Up to Week 52 | Number of episodes with Hgb level of more than 13.0 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented. |
| Secondary | Area Under Plasma Concentration Curve From Time Zero to 4 Hours (AUC [0 - 4]) of Plasma Daprodustat | 0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24 | Blood samples for Pharmacokinetic (PK) analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). NA indicates geometric co-efficient of variation could not be calculated as a single participant was analyzed. Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. PK population comprised of all daprodustat-treated participants from whom PK samples were collected and analyzed. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data. |
| Secondary | Maximum Concentration (Cmax) of Plasma Daprodustat | 0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24 | Blood samples for PK analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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