Recruiting soon

Pegmolesatide Regimens for Renal Anemia in Non-Dialysis CKD Patients

What is being tested

Pegmolesatide

Drug

Who is being recruted

Anemia

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

From 18 to 80 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: May 2025

See protocol details

Summary

Principal SponsorThe First Affiliated Hospital of Dalian Medical University

Study ContactHongli Lin, M.D.More contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on improving treatment for renal anemia in patients with chronic kidney disease (CKD) who are not on dialysis. It compares two different dosing strategies of a drug called Pegmolesatide for patients who have previously been treated with either rhuEPO or HIF-PHI. The goal is to determine which dosing regimen is more effective and safe, aiming to manage and maintain healthy hemoglobin (Hb) levels. This is important because maintaining the right Hb levels can significantly improve the quality of life for CKD patients by reducing symptoms of anemia, such as fatigue and weakness. Participants in the study are divided into two groups, each receiving Pegmolesatide with different dosing regimens based on their body weight. The first group receives a fixed dose, while the second group receives a dose adjusted according to their Hb levels every four weeks. The main focus is on how the patients' Hb levels change over the course of the first 24 weeks. By monitoring these changes, the study aims to establish the most effective and safest way to use Pegmolesatide for treating anemia in CKD patients. This includes looking at any potential risks or side effects related to the treatment.

Official TitleApplication of Pegmolesatide in Renal Anemia: the Effectiveness and Safety of Switching to Two Different Regimens of Pegmolesatide in Patients With Non Dialysis CKD Treated With rhuEPO or HIF-PHI

NCT06946394

Principal SponsorThe First Affiliated Hospital of Dalian Medical University

Study ContactHongli Lin, M.D.More contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaHematologic DiseasesHemic and Lymphatic Diseases

Criteria

6 inclusion criteria required to participate

Age ≥ 18 years old and ≤ 80 years old, gender not limited;

Weight ≥ 45kg; Body Mass Index (BMI) ≥ 18.5kg/m^2;

Diagnosed with CKD ≥ 6 months and estimated glomerular filtration rate (eGFR) ≥ 15mL/min/1.73m^2 before enrollment, and<60 mL/min/1.73m^2 (estimated GFR using CKD-EPI formula), with no expected renal replacement therapy plan during the study period;

rHuEPO or HIF-PHI should be used for ≥ 4 weeks and ≤ 12 weeks;

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10 exclusion criteria prevent from participating

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;

Known to be allergic to iron agents or polyethylene glycol;

Received red blood cell or whole blood transfusion therapy within the three months prior to randomization;

Have received oral or intravenous immunosuppressive or glucocorticoid therapy within the 12 weeks prior to randomization;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

initial phase：Body weight ≤60kg, initial dose 2.0mg; Body weight \> 60kg, initial dose 3.2mg, once every 4 weeks by subcutaneous injection. Adjustment phase：based on Hb levels and its changes every 4 weeks, once a month by subcutaneous injection.

Group II

Active Comparator

initial phase：0.04mg/kg body weight, once every 4 weeks by subcutaneous injection. Adjustment phase：based on Hb levels and its changes every 4 weeks, once a month by subcutaneous injection.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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