Use of Pegmolesatide in Renal Anemia: Efficacy and Safety of Switching to Pegmolesatide in Non-dialysis CKD Patients Treated With rhuEPO or HIF-PHI

Use of Pegmolesatide in Renal Anemia: Efficacy and Safety of Switching to Pegmolesatide in Non-dialysis CKD Patients Treated With rhuEPO or HIF-PHI

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.

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.

• 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.