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NCT02865850 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)
A Phase 3 study, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 369
- Enrollment target
NCT02865850: Completed Phase 3 study, sponsored by Akebia Therapeutics.
NCT02865850 is a Phase 3 study that has completed, run by Akebia Therapeutics. The registered enrollment target is 369 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02865850, a Phase 3 study, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 369 participants
- Enrollment target
Study Summary
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).
Primary Outcome
The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Primary Efficacy Period was calculated as the average Hb value over Weeks 24 to 36. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with Baseline hemoglobin concentration (\<9.5 versus ≥9.5 g/dL), geographic region (United States \[US\] versus Europe
Interventions
- DRUG Vadadustat
- DRUG Darbepoetin alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2016-07 |
| Est. Completion | 2020-03-30 |
| Phase | Phase 3 |
What the finished NCT02865850 record still lists
NCT02865850 is an interventional study that assigns participants to a tested intervention. The registered 369 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Vadadustat is the first listed.
NCT02865850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02865850 about?
NCT02865850 is a clinical study titled "Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)". A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).
What is the current status of trial NCT02865850?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 369 participants. The study started on 2016-07. Estimated completion is 2020-03-30.
What interventions are being tested in trial NCT02865850?
The interventions under investigation include: Vadadustat (DRUG), Darbepoetin alfa (DRUG).
Who is sponsoring clinical trial NCT02865850?
This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02865850's enrollment target sits among peer trials
369 995th of 2000 higher than 1,005 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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