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New pill could replace needles for anemia in dialysis patients

NCT ID NCT07300111

What the study statuses mean

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new pill called daprodustat against a standard injectable drug (darbepoetin alfa) for treating anemia in people on hemodialysis. About 100 Chinese adults will take either the pill daily or the injection weekly for 28 weeks. The goal is to see if the pill works just as well at raising hemoglobin 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 (a pill that stimulates red blood cell production)
What this could lead to
If successful, daprodustat could offer a convenient once-daily pill option to manage anemia in dialysis patients, potentially replacing injectable treatments.
What could go wrong
This is a non-inferiority trial, so it may only show that daprodustat is as good as, not better than, existing therapy. It is also limited to Chinese patients on hemodialysis, so results may not apply broadly.

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

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jul 2027

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

18 to 75 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: 1. Female or male,age 18 to 75 2. Weight 45 to 100 kg 3. Receiving hemodialysis (including hemodiafiltration) consistently three times a week for at least 12 weeks prior to screening. 4. Patients with pre-dialysis Hb levels measured after the maximum interdialytic interval at Scr Visit 1 and Scr Visit 2 (1 week after the start of observation) of ≥95 g/L and \<120 g/L and a difference (in absolute value) between Scr Visit 1 and Scr Visit 2 of ≤15 g/L. 5. TSAT \>20% and ferritin \>100 μg/L 6. Use of one and the same ESA for 10 weeks prior to screening 7. Darbepoetin alfa 10 to 60 μg per week, epoetin (including biosimilars) 1500 to 10000 international units (IU) per week. Exclusion Criteria: 1. History of bone-marrow hypoplasia, pure red cell aplasia, pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes. 2. History of malignancy. 3. Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding within 12 weeks prior to screening or during a period from screening to Day 1. 4. Myocardial infarction, acute coronary syndrome, stroke, or transient ischemic attack: Diagnosed within 12 weeks prior to screening or during a period from screening to Day 1 5. Chronic Class III or IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system. 6. poorly controlled hypertension. 7. Current unstable active liver or biliary disease. 8. History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product. 9. Use or planned use of any prescription or non-prescription drugs or dietary supplements that are prohibited during the study period. 10. Use of an investigational agent within 30 days or five half lives of the investigational agent (whichever is longer) 11. Use of daprodustat or other HIF-PHI within 4 weeks prior to screening, or any prior treatment with daprodustat for a treatment duration of \> 4weeks. 12. QTc \>500 milliseconds (msec); or QTc \>530 msec in subjects with bundle branch block. 13. ALT or AST \>2 upper limit of normal (ULN),or bilirubin \>1.5×ULN.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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