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Kidney anemia pill study for kids pulled before it started

NCT ID NCT05082584

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study was designed to test a once-daily pill called vadadustat for treating anemia in children with chronic kidney disease. The goal was to see if the drug could safely raise red blood cell levels without the need for injections. However, the study was withdrawn before enrolling any participants, so no results are available.

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.

Expected to start

Jan 2025

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

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

4 months to 16 years

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: * Diagnosis of anemia of chronic kidney disease (CKD) * Diagnosis of non-dialysis-dependent (NDD) CKD with an estimated glomerular filtration rate of greater than (\>) 10 and less than (\<) 60 milliliters/minute/1.73 meters\^2 (mL/min/1.73 m\^2 ) or diagnosis of dialysis dependent (DD) CKD * Mean screening hemoglobin (Hb) \<10.0 grams/deciliters (g/dL) * Transferrin Saturation ≥ 20% Exclusion Criteria: * Anemia due to a cause other than CKD * Active bleeding or recent clinically significant blood loss * Treatment with an erythropoiesis-stimulating agents (ESA) within 8 weeks prior to Screening * History of sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia * Red Blood Cells transfusion within 4 weeks * Serum albumin level \<2.5 g/dL * Uncontrolled hypertension * Active malignancy or treatment for malignancy within the past 2 years prior to Screening * Evidence of iron overload or diagnosis of hemochromatosis * Known hypersensitivity to vadadustat or any excipients in vadadustat tablet

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Conditions

The condition(s) this trial relates to.

anemia anemia due to chronic disorder chronic renal failure syndrome kidney disorder

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

  • Research Site

    Hackensack, New Jersey, 07601, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.