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New oral drug could replace injections for kidney anemia

NCT ID NCT07565701

Disease control Sponsor: Geoff Block 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a gradual switch from the injected drug Epogen to an oral medication called vadadustat for people with anemia who are on dialysis. The goal is to see if patients can stay on vadadustat long-term without stomach issues or drops in red blood cell levels. About 100 adults will take part, and the main measure is how many remain on vadadustat after 20 weeks.

What this could mean

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

Active substance
vadadustat (oral drug) and epoetin alfa (Epogen)
What this could lead to
If successful, this could offer a more convenient oral option for managing anemia in dialysis patients, potentially with fewer side effects.
What could go wrong
This is a small, early-phase trial focused on tolerability, not long-term outcomes. The drug may still cause gastrointestinal issues or fail to maintain stable hemoglobin levels.

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 100 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

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 ≥18 years of age * Receiving outpatient in-center hemodialysis for ESKD at least TIW (prescribed) * Currently receiving EPO (active administration, not on HOLD) * Less than or equal to 0.75 g/d difference between last 2 Hgb values prior to Screening, with neither Hgb \<9 g/dL * Average of last 2 Hgb between 9-11.4 g/dL (inclusive) prior to Screening * Central Screening Hgb 9-11.4 g/dL (inclusive) * Central Screening transferrin saturation greater than or equal to 20% * Central Screening serum ferritin greater than or equal to 100 ng/mL * 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 per United States Prescribing Information (USPI) including Screening liver function tests greater than 3x the upper limit of normal (ULN) * Electronic Medical Record (EMR)-documented history of cirrhosis or active, acute liver disease * EMR-documented history of currently active malignancy excluding non-melanomatous skin cancer and in-situ cervical cancer * Concomitant use of HIF-PHI or OAT1/OAT3 inhibitors (probenecid, rifampicin, gemfibrozil, or teriflunomide) * Unable to comply with study requirements or in the opinion of a healthcare provider or member of the central study team, not clinically stable to participate in the study * Documented unplanned absence from dialysis greater than or equal to 3 times in 30 days prior to Screening (excluding rescheduled dialysis treatments) * 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

As listed by the trial registrant

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

Anemia associated with chronic kidney disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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