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Could a pill replace needles for anemia in dialysis?

NCT ID NCT06520826

Disease control Sponsor: USRC Kidney Research 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an oral drug called vadadustat (Vafseo) for treating anemia in people with end-stage kidney disease who are on hemodialysis. About 2,200 adults will be randomly assigned to take vadadustat three times a week or continue standard injectable treatments. The goal is to see if the oral drug is as safe and effective at managing anemia and reducing hospitalizations or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vadadustat (Vafseo)
What this could lead to
If successful, this could offer a more convenient oral option for managing anemia in dialysis patients, potentially reducing hospitalizations.
What could go wrong
This is a large Phase 3 trial, but it's comparing to existing treatments, not testing a cure. Risks include side effects and the possibility that vadadustat is no better or worse than current standard care.

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

About 2,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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 patients greater than or equal to 18 years of age. * Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease. * Currently prescribed or eligible for erythropoiesis-stimulating agent based on approved facility policy * Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure. Exclusion Criteria: * Contraindication to receive vadadustat or any of its known constituents per USPI. * Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide). * Unable to comply with study requirements or in the opinion of a healthcare provider or a member of the central study team, not clinically stable to participate in the study. * Pregnant at time of consent (per subject self-report).

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Conditions

The condition(s) this trial relates to.

anemia due to chronic disorder 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

  • Dallas Renal Group

    Dallas, Texas, 75230, United States

  • Nephrology and Hypertension Specialists, PC

    Dalton, Georgia, 30720, United States

  • US Renal Care - Gallup

    Gallup, New Mexico, 87301, United States

  • US Renal Care - Live Oak

    Live Oak, Texas, 78233, United States

  • USRC Kidney Research

    Lone Tree, Colorado, 80124, United States

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