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NCT02892149 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)
A Phase 3 study of Anemia and Dialysis-Dependent Chronic Kidney Disease, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,554
- Enrollment target
- 20
- Study locations
NCT02892149: Completed Phase 3 study of Anemia and Dialysis-Dependent Chronic Kidney Disease, sponsored by Akebia Therapeutics.
NCT02892149 is a Phase 3 study of Anemia and Dialysis-Dependent Chronic Kidney Disease that has completed, run by Akebia Therapeutics. The registered enrollment target is 3,554 participants, above the 378-participant average among 72 other Anemia trials with a reported enrollment target (840% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02892149, a Phase 3 study of Anemia and Dialysis-Dependent Chronic Kidney Disease, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,554 participants
- Enrollment target
- 20
- Study locations
Study Summary
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with 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 (\<10.0 versus ≥10.0 g/dL), geographic region (United States \[US\] versus Euro
Conditions Studied
Interventions
- DRUG Vadadustat
- DRUG Darbepoetin alfa
Study Locations (20)
California
- Research Site - Anaheim
- Research Site #1 - Bakersfield
- Research Site #2 - Bakersfield
- Research Site - Canyon Country
- Research Site - Chula Vista
- Research Site - Downey
- Research Site - El Centro
- Research Site - Escondido
- Research Site - Fairfield
- Research Site - Glendale
- Research Site #1 - Granada Hills
- Research Site #2 - Granada Hills
- Research Site - La Habra
- Research Site - La Mesa
- Research Site - Lakewood
- Research Site - Long Beach
- Research Site - Long Beach
Alabama
- Research Site - Huntsville
Arizona
- Research Site - Mesa
Arkansas
- Research Site - Pine Bluff
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,554 participants |
| Start Date | 2016-08 |
| Est. Completion | 2020-03-30 |
| Phase | Phase 3 |
What the finished NCT02892149 record still lists
NCT02892149 is an interventional study that assigns participants to a tested intervention. Its 3,554 participants enrollment target places it among the larger protocols in the corpus, above the 378-participant average among 72 other Anemia trials with a reported enrollment target (840% higher).
The record links to 2 conditions, with Anemia appearing as the primary indexed condition, and to 2 interventions - of which Vadadustat is the first listed.
NCT02892149 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT02892149 about?
NCT02892149 is a clinical study titled "Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)". A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)
What is the current status of trial NCT02892149?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,554 participants. The study started on 2016-08. Estimated completion is 2020-03-30.
What conditions does trial NCT02892149 study?
This clinical trial studies the following conditions: Anemia, Dialysis-Dependent Chronic Kidney Disease.
What interventions are being tested in trial NCT02892149?
The interventions under investigation include: Vadadustat (DRUG), Darbepoetin alfa (DRUG).
Who is sponsoring clinical trial NCT02892149?
This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02892149 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02892149's enrollment target sits among peer trials
3,554 1st of 72 higher than 72 of 72 other Anemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anemia 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.
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