Trial · NCT02791763
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 66
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants | Weeks 40 to 52 | The mean hemoglobin during the primary efficacy evaluation period in ND participants was estimated by a statistical model using Mixed Model Repeated Measures (MMRM). |
| 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) | 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. |
| 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) | 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. |
| Secondary | Change From Baseline in Hgb at Week 4 in ND Participants | Baseline (Day 1) and 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. Data for change from Baseline in Hgb at Week 4 in ND participants is presented. |
| Secondary | Change From Baseline in Hgb at Week 4 in PD Participants | Baseline (Day 1) and 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. Data for change from Baseline in Hgb at week 4 in PD participants is presented. |
| Secondary | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and 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. |
| Secondary | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and 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. |
| Secondary | Number of PD Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and 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. |
| Secondary | Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and 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. |
| Secondary | Daprodustat Dose Level by Visit in ND Participants | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48 | Daprodustat dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75). |
| Secondary | Epoetin Beta Pegol Dose Level by Visit in ND Participants | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48 | 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). |
| Secondary | Daprodustat Dose Level by Visit in PD Participants | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48 | Daprodustat dose level at each assessment visit for PD participants is presented using 25th percentile (P25), median, and 75th percentile (P75). |
| Secondary | Duration of Treatment Interruption Due to Hgb >13 g/dL in ND Participants | Up to Week 52 | 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. |
| Secondary | Duration of Treatment Interruption Due to Hgb >13 g/dL in PD Participants | Up to Week 52 | 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. |
| Secondary | Number of Dose Adjustments in ND Participants | Up to Week 52 | Number of dose adjustments in ND participants is presented. |
| Secondary | Number of Dose Adjustments in PD Participants | Up to Week 52 | Number of dose adjustments in PD participants is presented. |
| Secondary | Hgb Values at Each Assessment Visit in ND Participants | 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 ND participants is presented. |
| Secondary | Hgb Values at Each Assessment Visit in PD Participants | 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 PD participants is presented. |
| Secondary | Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants | Baseline (Day 1), 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 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. |
| Secondary | Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants | Baseline (Day 1), 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 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. |
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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