Two Different Regiments of Pegmolesatide for Anemia in Patients With Chronic Kidney Disease Not Receiving Dialysis

Last updated: April 23, 2025
Sponsor: The First Affiliated Hospital of Dalian Medical University
Overall Status: Active - Not Recruiting

Phase

4

Condition

Anemia

Treatment

Pegmolesatide

Clinical Study ID

NCT06946394
HSM-20039-402
  • Ages 18-80
  • All Genders

Study Summary

This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients which had received Recombinant human erythropoietin (rHuEPO) or Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) treatment were randomized in a 1:1 ratio to receive Pegmolesatide with different administration regimens.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

  3. 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 usingCKD-EPI formula), with no expected renal replacement therapy plan during the studyperiod;

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

  5. During the 28days and 3days before randomization, with Hb ≥ 70g/L and < 110g/L;

  6. Understand the research procedure and voluntarily sign an informed consent form (ICF) in writing.

Exclusion

Exclusion Criteria:

  1. Known to have hematological disorders or other diseases that cause anemia other thanchronic 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 monthsprior to randomization;

  4. Have received oral or intravenous immunosuppressive or glucocorticoid therapy withinthe 12 weeks prior to randomization;

  5. Individuals with poor blood pressure control;

  6. C-reactive protein ≥ 30mg/L within the first 3 days of randomization;

  7. Pregnant and lactating women, women of childbearing age who have a positive urine β

  • HCG test result before the trial, or those who have a pregnancy plan during thestudy period;
  1. Assessment of cardiac function level III or IV within the first 3 days ofrandomization;

  2. Within the first 3 days of randomization, the liver function was assessed as GradeC;

  3. Researchers believe that subjects with any other factors that are not suitable forparticipating in this trial.

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Pegmolesatide
Phase: 4
Study Start date:
May 01, 2025
Estimated Completion Date:
November 30, 2026

Study Description

This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients were randomized in a 1:1 ratio to Pegmolesatide optimize medication regimen group and Pegmolesatide standard medication regimen group. Patients in the investigational group received 2.0 mg (in patients weighing ≤60 kg) or 3.2 mg (in patients weighing >60 kg) as the initial dose, the initial dose of the control group was 0.04mg/kg, then were adjusted for every 4 weeks based on Hb levels and its changes. The primary endpoint was the change in Hb levels from baseline in week 24.