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New anemia pill for dialysis patients tested against standard shots

NCT ID NCT06901505

Disease control Sponsor: Akebia Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study tests a new pill, vadadustat, taken three times a week, against the usual injected medicine for anemia in people with kidney failure who are on dialysis. About 350 adults will take part to see if the pill can safely keep their red blood cell levels in a healthy range. The goal is to offer a more convenient treatment option.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

353 people

The number who actually took part.

Started

Jul 2025

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult participants ≥18 years of age. * Receiving outpatient in-center hemodialysis for ESKD at least three times a week. * Currently prescribed or meets criteria for ESA based on approved facility policy. * Hb \> 8 grams per deciliter (g/dl). * Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20%. * Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure. * For selected sites, individuals who opt to participate in the RBC sub-study must meet the following inclusion criteria: * Currently prescribed or will be prescribed methoxy polyethylene glycol-epoetin beta. * Hb \<11.5 g/dL Exclusion Criteria: * Contraindication to receive vadadustat per United States prescribing information (USPI) as determined by the treating health care provider. * Concomitant use of any hypoxia-inducible factor prolyl hydroxylase inhibitor(HIF-PHI). * Known cirrhosis or active, acute liver disease. * Unable to comply with study requirements or compliance with attending dialysis treatments as prescribed, or in the opinion of the treating physician or Investigator, not clinically stable to participate in the study. * Pregnant at the time of consent (per participant self-report). * Any other reason, which in the opinion of the Investigator, would make the participants unsuitable for participation in the study. * For selected sites, individuals who opt to participate in the RBC sub-study must also not meet the following exclusion criteria: * History of, or currently diagnosed with, any hematological disease, such as sickle cell disease, thalassemia, hemochromatosis, Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency, myelodysplastic syndromes, or any other blood disorder that could interfere with the study outcomes. * Participants will receive a blood transfusion within 3 months prior to the initiation of the study. * History of or currently diagnosed with chronic lung disease

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Conditions

The condition(s) this trial relates to.

anemia due to chronic disorder chronic renal failure syndrome end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia of chronic kidney disease

Contacts and locations

Locations

  • DaVita Research Site

    Montgomery, Alabama, 36117-7306, United States

  • DaVita Research Site

    Hartford, Connecticut, 06112-1260, United States

  • DaVita Research Site

    Middlebury, Connecticut, 06705-3893, United States

  • DaVita Research Site

    Columbus, Georgia, 31904-3604, United States

  • DaVita Research Site

    Minneapolis, Minnesota, 55435-1807, United States

  • DaVita Research Site

    Henderson, Nevada, 89052-5548, United States

  • DaVita Research Site

    Las Vegas, Nevada, 89128-0804, United States

  • DaVita Research Site

    El Paso, Texas, 79835-2200, United States

  • DaVita Research Site

    Houston, Texas, 77054-3836, United States

  • DaVita Research Site

    San Antonio, Texas, 78258-4800, United States

  • DaVita Research Site

    The Woodlands, Texas, 77384-3024, United States

  • DaVita Research Site

    Norfolk, Virginia, 23502-3235, United States

  • DaVita Research Site #1

    Minneapolis, Minnesota, 55435-1807, United States

  • DaVita Research Site #1

    El Paso, Texas, 79835-2200, United States

  • DaVita Research Site #1

    Houston, Texas, 77054-3836, United States

  • DaVita Research Site #1

    San Antonio, Texas, 78258-4800, United States

  • DaVita Research Site #1

    Norfolk, Virginia, 23502-3235, United States

  • DaVita Research Site #2

    San Antonio, Texas, 78258-4800, United States

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