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New combo therapy aims to boost red blood cells in dialysis patients

NCT ID NCT07045155

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tests a new drug called pegmolesatide, alone or combined with roxadustat, to treat anemia in 240 adults on dialysis for chronic kidney disease. Participants currently on another anemia drug (rHuEPO) will switch to one of three treatment plans for 24 weeks. The goal is to see which approach best raises and stabilizes 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
Pegmolesatide (a drug to stimulate red blood cell production), sometimes combined with roxadustat
What this could lead to
If successful, this could offer a more effective or convenient way to manage anemia in people on dialysis, potentially improving energy and quality of life.
What could go wrong
This is a phase 4 study with a modest size (240 participants) and open-label design, which can introduce bias. The combination therapy may also carry unknown side effects.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 240 people

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

Started

Aug 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 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. Aged ≥18 years and ≤80 years, with no restrictions on gender. 2. Body weight ≥40 kg and body mass index (BMI) ≥18 kg/m². 3. Subjects who have received hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment; 4. Subjects who have been receiving erythropoiesis-stimulating agents (ESAs) for ≥4 weeks prior to randomization, with an average weekly dose \>6000 IU in the last 4 weeks (equivalent dose converted to short-acting EPO \>6000 IU, calculated as the total amount of short-acting EPO used in the last 4 weeks divided by 4); 5. The most recent Hb value during the screening period and the average Hb value between screening and baseline visits must be ≥70 to \<110 g/L; 6. Hemodialysis patients with serum ferritin levels ≥200 μg/L; peritoneal dialysis patients with serum ferritin levels ≥100 μg/L, and the investigator determines that renal transplant is not required during the trial; 7. Understanding the study procedures and voluntarily signing the Informed Consent Form (ICF). Exclusion Criteria: 1. Known to have active malignancy, polycystic kidney disease, hematologic disorders (including congenital and acquired anemias such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndromes, hemolytic anemia, and coagulation disorders), or other causes of anemia (such as gastrointestinal bleeding or hookworm disease); 2. Known to have experienced stroke, transient ischemic attack, myocardial infarction, thromboembolic events (deep vein thrombosis), pulmonary embolism, or other serious cardiopulmonary diseases within the past 6 months; 3. Received anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization; 4. Known to have received red blood cell or whole blood transfusion within 12 weeks prior to the study. 5. History of significant infection within 4 weeks before randomization as determined by the investigator. 6. Confirmed blood pressure measurements at rest and in a conscious state using standard measurement methods, with at least three non-consecutive day readings reaching or exceeding systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg within 4 weeks before enrollment, or changes in antihypertensive medication treatment. The primary basis for judgment is clinic-measured blood pressure values, but "white coat hypertension" should be excluded. 7. Known allergy to iron agents or polyethylene glycol. 8. Pregnant or breastfeeding women, women of childbearing age with a positive blood β-HCG test result before the trial, or those planning to become pregnant during the study period. 9. Scheduled for elective surgery during the trial period. 10. Presence of any other factors that the investigator deems unsuitable for participation in this trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100000, China

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