A Longer-Lasting anemia shot: could pegmolesatide replace frequent dosing?
NCT ID NCT06946394
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This trial tests whether switching to pegmolesatide, a long-acting injection given once a month, can safely maintain hemoglobin levels in people with chronic kidney disease who are not on dialysis and already take other anemia medications. About 160 adults will be randomly assigned to one of two pegmolesatide dosing schedules. Researchers will compare how well each schedule keeps hemoglobin in a healthy range over 24 weeks, with a 24-week extension to check longer-term effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pegmolesatide (also known as EPO-018B), an injection given once every 4 weeks
- What this could lead to
- If it works, this could offer a more convenient, less frequent treatment option for managing anemia in chronic kidney disease patients who do not need dialysis.
- What could go wrong
- This is a phase 4 trial with 160 participants, so results may not apply to everyone. Switching treatments could cause side effects or fail to keep hemoglobin levels in the target range.
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 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2027
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, regardless of gender; 2. Body weight ≥45 kg; Body Mass Index (BMI) ≥18.5 kg/m²; 3. Diagnosed with chronic kidney disease (CKD) complicated by renal anemia, with an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m² before randomization (GFR estimation using the CKD-EPI formula); Undergoing continuous treatment with rHuEPO or HIF-PHI for ≥2 weeks before randomization; 4. Hemoglobin (Hb) level measured within 7 days before randomization ≥70 g/L and \< 110 g/L; 5. Understanding the study procedures and voluntarily signing the Informed Consent Form (ICF) * Exclusion Criteria: 1. Known to have hematological disorders or other diseases that cause anemia other than chronic kidney disease (CKD), such as primary pure red cell aplasia (PRCA), homozygous sickle cell disease, thalassemia/Cooley's anemia, multiple myeloma, hemolytic anemia, and myelodysplastic syndrome, or malignant tumors; 2. Known to be allergic to iron agents or polyethylene glycol; 3. Received red blood cell or whole blood transfusion therapy within the three months prior to randomization; 4. Having received or planned to receive anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization or during the study treatment period; 5. Poorly controlled blood pressure (specific criteria for determination are referenced in Appendix II); 6. C-reactive protein (CRP) ≥30 mg/L within 7 days prior to randomization; 7. Pregnant or breastfeeding women, women of childbearing age with a positive urine β-HCG test result prior to the study, or those planning to become pregnant during the study; 8. Assessed as having Class C liver function within 7 days prior to randomization (Child-Pugh classification, details in Appendix IV); 9. Assessed as having Class III or IV cardiac function within 28 days prior to randomization (details in Appendix III); 10. Subjects deemed by the investigator to have any other factors that make them unsuitable for participation in this study.
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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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Poster
RECRUITINGDalian, Liaoning, China