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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 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.

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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.

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

FieldValue
Enrollment Target 353 participants
Start Date 2025-07-24
Est. Completion 2026-08
Phase Phase 3

Sponsor

Akebia Therapeutics

24 total trials

What the Registry Record Tells You About NCT06901505

The ClinicalTrials.gov registry entry for NCT06901505 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 353 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 574-participant average among 4 other Anemia of Chronic Kidney Disease trials with a reported enrollment target (39% 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 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 reports 18 study locations spanning 7 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.