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NCT06901505 · ClinicalTrials.gov registry record · Phase 3
To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
A Phase 3 study of Anemia of Chronic Kidney Disease, sponsored by Akebia Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 353
- Enrollment target
- 18
- Study locations
NCT06901505: Active Phase 3 study of Anemia of Chronic Kidney Disease, sponsored by Akebia Therapeutics.
NCT06901505 is a Phase 3 study of Anemia of Chronic Kidney Disease that is active but no longer recruiting, run by Akebia Therapeutics. The registered enrollment target is 353 participants, below the 574-participant average among 4 other Anemia of Chronic Kidney Disease trials with a reported enrollment target (39% lower). The trial reports 18 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06901505, a Phase 3 study of Anemia of Chronic Kidney Disease, is active but no longer recruiting, sponsored by Akebia Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 353 participants
- Enrollment target
- 18
- Study locations
Study Summary
This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). A subset of sites will participate in a red blood cell (RBC) sub-study where changes in the phenotype of RBCs in response to vadadustat treatment relative to methoxy polyethylene glycol-epoetin beta treatment in DD-CKD participants with anemia will be assessed. A separate informed consent form (ICF) will be signed by these participants who opt to be in the RBC sub-study. Of the 350 participants in the main study, approximately 28 participants will also be enrolled into the RBC sub-study. The total duration of the study is approximately 35 Weeks including screening and follow-up.
Conditions Studied
Interventions
- DRUG Erythropoiesis-Stimulating Agent (ESA)
- DRUG Vadadustat
Study Locations (18)
Texas
- DaVita Research Site #1 - El Paso
- DaVita Research Site - El Paso
- DaVita Research Site #1 - Houston
- DaVita Research Site - Houston
- DaVita Research Site #1 - San Antonio
- DaVita Research Site #2 - San Antonio
- DaVita Research Site - San Antonio
- DaVita Research Site - The Woodlands
Connecticut
- DaVita Research Site - Hartford
- DaVita Research Site - Middlebury
Minnesota
- DaVita Research Site #1 - Minneapolis
- DaVita Research Site - Minneapolis
Nevada
- DaVita Research Site - Henderson
- DaVita Research Site - Las Vegas
Virginia
- DaVita Research Site #1 - Norfolk
- DaVita Research Site - Norfolk
Alabama
- DaVita Research Site - Montgomery
Georgia
- DaVita Research Site - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2025-07-24 |
| Est. Completion | 2026-08 |
| Phase | Phase 3 |
What the registry record for NCT06901505 still lists
NCT06901505 is an interventional study that assigns participants to a tested intervention. The registered 353 participants enrollment target is mid-sized for trials with a published cap, below the 574-participant average among 4 other Anemia of Chronic Kidney Disease trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Anemia of Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Erythropoiesis-Stimulating Agent (ESA) is the first listed.
NCT06901505 lists 18 locations in 7 states (Texas, Connecticut, Minnesota).
Frequently Asked Questions
What is clinical trial NCT06901505 about?
NCT06901505 is a clinical study titled "To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis". This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidne...
What is the current status of trial NCT06901505?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 353 participants. The study started on 2025-07-24. Estimated completion is 2026-08.
What conditions does trial NCT06901505 study?
This clinical trial studies the following conditions: Anemia of Chronic Kidney Disease.
What interventions are being tested in trial NCT06901505?
The interventions under investigation include: Erythropoiesis-Stimulating Agent (ESA) (DRUG), Vadadustat (DRUG).
Who is sponsoring clinical trial NCT06901505?
This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06901505 being conducted?
This trial has 18 study locations across Alabama, Connecticut, Georgia, Minnesota, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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