New combo therapy aims to boost red blood cells in dialysis patients
NCT ID NCT07045155
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100000, China
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Other studies related to the condition(s) this trial covers.
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- Could less dialysis be better for seniors? new study aims to find out