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NCT02648347 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease
A Phase 3 study of Anemia and Non-Dialysis-Dependent Chronic Kidney Disease, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,751
- Enrollment target
- 20
- Study locations
NCT02648347: Completed Phase 3 study of Anemia and Non-Dialysis-Dependent Chronic Kidney Disease, sponsored by Akebia Therapeutics.
NCT02648347 is a Phase 3 study of Anemia and Non-Dialysis-Dependent Chronic Kidney Disease that has completed, run by Akebia Therapeutics. The registered enrollment target is 1,751 participants, above the 403-participant average among 72 other Anemia trials with a reported enrollment target (334% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02648347, a Phase 3 study of Anemia and Non-Dialysis-Dependent Chronic Kidney Disease, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,751 participants
- Enrollment target
- 20
- Study locations
Study Summary
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-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 Hb concentration (\<9.5 versus ≥9.5 grams per deciliter \[g/dL\]), geographic region (United States \[US
Conditions Studied
Interventions
- DRUG Vadadustat
- DRUG Darbepoetin alfa
Study Locations (20)
California
- Research Site - Anaheim
- Research Site - Bakersfield
- Research Site #1 - Chula Vista
- Research Site #2 - Chula Vista
- Research Site #1 - Fountain Valley
- Research Site #2 - Fountain Valley
- Research Site - Glendale
- Research Site - Granada Hills
- Research Site - La Mesa
- Research Site - Laguna Hills
- Research Site - Long Beach
- Research Site - Long Beach
- Research Site - Los Angeles
Arizona
- Research Site - Glendale
- Research Site - Mesa
- Research Site - Phoenix
- Research Site - Tucson
- Research Site - Tucson
Alabama
- Research Site - Huntsville
- Research Site - Tuscumbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,751 participants |
| Start Date | 2015-12 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 3 |
What the finished NCT02648347 record still lists
NCT02648347 is an interventional study that assigns participants to a tested intervention. Its 1,751 participants enrollment target places it among the larger protocols in the corpus, above the 403-participant average among 72 other Anemia trials with a reported enrollment target (334% 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.
NCT02648347 names 20 study sites across 3 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT02648347 about?
NCT02648347 is a clinical study titled "Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease". A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)
What is the current status of trial NCT02648347?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,751 participants. The study started on 2015-12. Estimated completion is 2020-07-31.
What conditions does trial NCT02648347 study?
This clinical trial studies the following conditions: Anemia, Non-Dialysis-Dependent Chronic Kidney Disease.
What interventions are being tested in trial NCT02648347?
The interventions under investigation include: Vadadustat (DRUG), Darbepoetin alfa (DRUG).
Who is sponsoring clinical trial NCT02648347?
This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02648347 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02648347's enrollment target sits among peer trials
1,751 7th of 72 higher than 66 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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