A Longer-Lasting anemia shot: could pegmolesatide replace frequent dosing?

NCT ID NCT06946394

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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 Results may not be published yet.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

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Status unknown
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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

Phase 4

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

Participants

About 160 people

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

Started

May 2025

Expected to finish

Dec 2027

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, 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

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  1. The places running it

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

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Poster

    RECRUITING

    Dalian, Liaoning, China