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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04313153
The ClinicalTrials.gov registry entry for NCT04313153 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 319 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 423-participant average among 72 other Anemia trials with a reported enrollment target (25% lower). The listed sponsor is Akebia Therapeutics, which has 24 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.
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Related
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