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New pill shows promise for anemia in kids with kidney disease

NCT ID NCT05682326

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a drug called daprodustat in children aged 3 months to under 18 years who have anemia due to chronic kidney disease. The goal was to see how the drug moves through the body and if it is safe. Only 4 children took part, and they received the drug for up to 52 weeks. The study looked at side effects and changes in red blood cell levels.

What this could mean

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

Active substance
daprodustat
What this could lead to
If successful, this could provide a new treatment option for anemia in children with chronic kidney disease, potentially reducing the need for injections.
What could go wrong
This was a very small study with only 4 participants, so results may not apply to all children. The drug also carries risks like blood clots and high blood pressure.

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

4 people

The number who actually took part.

Started

Sep 2023

Finished

Mar 2025

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

3 months to 17 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: * Participant must be 3 months to less than (\<)18 years of age. * Anemia associated with CKD stage 3, 4, 5 (not on dialysis) or who have dialysis-dependent CKD, defined as Hgb 7.0 to 11.0 g/dL (if not using erythropoiesis stimulating agents \[ESAs\]) or Hgb 9.5 to 12.0 g/dL if using ESAs. * Written informed consent or assent as appropriate. Exclusion Criteria: * Kidney transplant recipient with a functioning allograft. * Scheduled for elective kidney transplantation within 3 months. * Transferrin saturation (TSAT) \< 20 percent (%), or Ferritin \<25 nanogram (ng)/milliliter (mL). * History of bone marrow aplasia or pure red cell aplasia. * Active hemolysis. * Other causes of anemia. * Active gastrointestinal bleeding within the last 4 weeks. * Active or previous malignancy within the last 2 years. * Acute or chronic infection requiring antimicrobial therapy. * History of significant thrombotic or thromboembolic events within the last 8 weeks. * Heart failure (HF) New York Heart Association (NYHA) Class IV * Uncontrolled hypertension. * Alanine aminotransferase (ALT) \>2× upper limit of normal (ULN), bilirubin \>1.5× ULN (unless bilirubin is fractionated and direct bilirubin \<35%), and cirrhosis or current unstable liver or biliary disease.

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Conditions

The condition(s) this trial relates to.

anemia anemia due to chronic disorder chronic renal failure syndrome

As listed by the trial registrant

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

Anaemia

Contacts and locations

Locations

  • GSK Investigational Site

    Aichi, 466-8650, Japan

  • GSK Investigational Site

    Saitama, 330-8777, Japan

  • GSK Investigational Site

    Tokyo, 162-8666, Japan

  • GSK Investigational Site

    Yangsan, 50612, South Korea

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