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ACTIVE NOT RECRUITING 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

NCT06901505 · View on ClinicalTrials.gov ↗

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

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06901505

The ClinicalTrials.gov registry entry for NCT06901505 describes a study currently listed as active not recruiting. 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 353 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 of Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions — of which Erythropoiesis-Stimulating Agent (ESA) 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: NCT06901505 reports 18 study locations spanning 7 distinct geographic areas — top geographies include Texas, Connecticut, Minnesota. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06901505?

The interventions under investigation include: Erythropoiesis-Stimulating Agent (ESA) (DRUG), Vadadustat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06901505?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial