Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT04313153 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 319 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akebia Therapeutics, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04313153 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04313153?
The interventions under investigation include: Vadadustat (DRUG), Darbepoetin alfa (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04313153?
This trial is sponsored by Akebia Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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