Trial · NCT02052310
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population) | Baseline (Day 1, Week 0), Week 28 to 52 | The ITT population included all randomized participants. | g/dL | MEAN |
| PRIMARY | Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population) | Baseline (Day 1, Week 0) up to Week 24 | The per protocol set (PPS) population included all participants in the full analysis set (FAS) population (all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment) who received at least 8 weeks of treatment and were without major protocol violations. | percentage of participants | NUMBER |
| SECONDARY | US (FDA Submission): Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (ITT Population) | Baseline (Day 1, Week 0) up to Week 24 | The ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Ex-US Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (PPS Population) | Baseline (Day 1, Week 0), Week 28 to 52 | The PPS population included all participants in the FAS population (all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment) who received at least 8 weeks of treatment and were without major protocol violations. Here, 'Number analyzed' signifies participants with non-missing data for this outcome measure at specified timepoint. | g/dL | MEAN |
| SECONDARY | Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 24 | Baseline (Day 1, Week 0), Week 12 to 24 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Number analyzed' signifies participants with non-missing data for this outcome measure at specified timepoints. | mg/dL | MEAN |
| SECONDARY | Mean Change From Baseline in Hb Levels Between Weeks 18 to 24 Regardless of Rescue Therapy in Participants Whose Baseline High Sensitivity C-Reactive Protein (Hs-CRP)> Upper Limit of Normal (ULN) | Baseline (Day 1, Week 0), Week 18 to 24 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | g/dL | MEAN |
| SECONDARY | Median Monthly IV Iron Use Per Patient-Exposure-Month (PEM) During Weeks 28 to 52 | Weeks 28 to 52 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | mg/PEM | MEDIAN |
| SECONDARY | Time to First RBC Transfusion | Baseline (Day 1, Week 0) up to last dose of study drug (maximum treatment duration was 227.9 weeks for roxadustat and 226.9 weeks for epoetin alfa) | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. | weeks | MEDIAN |
| SECONDARY | Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 8 to 12 | Baseline (Day 1, Week 0), Weeks 8 to 12 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Time to First Exacerbation of Hypertension During Weeks 28 to 52 | Weeks 28 to 52 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Exacerbation of Hypertension During Weeks 28 to 52 | Weeks 28 to 52 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. | percentage of participants | NUMBER |
| SECONDARY | Time to Achieve the First Hb Response up to Week 24 Censoring for Rescue Therapy | Baseline (Day 1, Week 0) up to Week 24 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Hb ≥10.0 g/dL Averaged Over Weeks 28 to 36 and 28 to 52, Regardless of Rescue Therapy | Weeks 28 to 36 and 28 to 52 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. | percentage of participants | NUMBER |
| SECONDARY | Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 36), Censoring for Rescue Therapy | Baseline (Day 1, Week 0), Week 28 to 36 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | 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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