Trial · NCT02791763
Outcomes66
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 66
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants | Weeks 40 to 52 | Intent to treat (ITT) Population comprised of cohort 1 participants (only erythropoiesis stimulating agent \[ESA\] users) and cohort 3 participants (both ESA users and ESA non-users) who were given randomization number with Hgb measurement at both Baseline and at least one scheduled visits following the Baseline. | Grams per deciliter (g/dL) | MEAN |
| 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 | Modified intent to treat (mITT) comprised of all ITT participants who had at least one Hgb measurement during the efficacy evaluation period. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | mITT Population | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hgb at Week 4 in ND Participants | Baseline (Day 1) and Week 4 | ITT Population. Only those participants with data available at the specified data points were analyzed. | g/dL | MEAN |
| SECONDARY | Change From Baseline in Hgb at Week 4 in PD Participants | Baseline (Day 1) and Week 4 | Efficacy peritoneal dialysis (PD) Population comprised of PD participants who were given randomization number with Hgb measurement at both Baseline and at least one scheduled visits following the Baseline. | g/dL | MEAN |
| SECONDARY | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | ITT Population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | ITT Population. Only those participants with data available at the specified data points were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Number of PD Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | Efficacy PD Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | Efficacy PD Population | Percentage of Participants | NUMBER |
| 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 | ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Milligrams per day (mg/day) | MEDIAN |
| 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 | ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Micrograms per 4 weeks | MEDIAN |
| 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 | Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | mg/day | MEDIAN |
| SECONDARY | Duration of Treatment Interruption Due to Hgb >13 g/dL in ND Participants | Up to Week 52 | ITT Population. Only those participants who had Hgb \> 13.0 g/dL of Hemocue were included in analysis. | Days | MEDIAN |
| SECONDARY | Duration of Treatment Interruption Due to Hgb >13 g/dL in PD Participants | Up to Week 52 | Efficacy PD Population. Only those participants who had Hgb \> 13.0 g/dL of Hemocue were included in analysis. | Days | MEDIAN |
| SECONDARY | Number of Dose Adjustments in ND Participants | Up to Week 52 | ITT Population | Number of dose adjustments | MEDIAN |
| SECONDARY | Number of Dose Adjustments in PD Participants | Up to Week 52 | Efficacy PD Population | Number of dose adjustments | MEDIAN |
| 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 | ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | g/dL | MEAN |
| 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 | Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | g/dL | MEAN |
| 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 | ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | g/dL | MEAN |
| 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 | Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | g/dL | MEAN |
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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