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NCT04313153 · ClinicalTrials.gov registry record · Phase 3
Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)
A Phase 3 study of Anemia, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 319
- Enrollment target
- 20
- Study locations
NCT04313153: Completed Phase 3 study of Anemia, sponsored by Akebia Therapeutics.
NCT04313153 is a Phase 3 study of Anemia that has completed, run by Akebia Therapeutics. The registered enrollment target is 319 participants, below the 423-participant average among 72 other Anemia trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04313153, a Phase 3 study of Anemia, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 319 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial will be conducted to demonstrate the efficacy and safety of vadadustat compared to darbepoetin alfa for the maintenance treatment of anemia in hemodialysis participants after conversion from current erythropoiesis-stimulating agent (ESA) therapy.
Primary Outcome
The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26, regardless of intercurrent events. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as
Conditions Studied
Interventions
- DRUG Vadadustat
- DRUG Darbepoetin alfa
Study Locations (20)
California
- Research Site - Chula Vista
- Research Site - Granada Hills
- Research Site - Los Angeles
- Research Site - Lynwood
- Research Site - Northridge
- Research Site - San Dimas
- Research Site - Whittier
Florida
- Research Site - Coral Gables
- Research Site - Tampa
- Research Site - Winter Park
Michigan
- Research Site - Pontiac
- Research Site - Roseville
Mississippi
- Research Site - Brookhaven
- Research Site - Tupelo
Missouri
- Research Site - Kansas City
- Research Site - St Louis
Colorado
- Research Site - Denver
Connecticut
- Research Site - Middlebury
Minnesota
- Research Site - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2020-05-27 |
| Est. Completion | 2022-06-22 |
| Phase | Phase 3 |
What the finished NCT04313153 record still lists
NCT04313153 is an interventional study that assigns participants to a tested intervention. The registered 319 participants enrollment target is mid-sized for trials with a published cap, below the 423-participant average among 72 other Anemia trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Anemia appearing as the primary indexed condition, and to 2 interventions - of which Vadadustat is the first listed.
NCT04313153 names 20 study sites across 9 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT04313153 about?
NCT04313153 is a clinical study titled "Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)". This trial will be conducted to demonstrate the efficacy and safety of vadadustat compared to darbepoetin alfa for the maintenance treatment of anemia in hemodialysis participants after conversion from current erythropoiesis-stimulating agent (ESA) therapy.
What is the current status of trial NCT04313153?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 319 participants. The study started on 2020-05-27. Estimated completion is 2022-06-22.
What conditions does trial NCT04313153 study?
This clinical trial studies the following conditions: Anemia.
What interventions are being tested in trial NCT04313153?
The interventions under investigation include: Vadadustat (DRUG), Darbepoetin alfa (DRUG).
Who is sponsoring clinical trial NCT04313153?
This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04313153 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04313153's enrollment target sits among peer trials
319 23rd of 72 higher than 50 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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