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.
Age ≥ 18 years old and ≤ 80 years old, gender not limited;
Weight ≥ 45kg; Body Mass Index (BMI) ≥ 18.5kg/m²;
Diagnosed with CKD ≥ 6 months and estimated glomerular filtration rate (eGFR) ≥ 15mL/min/1.73m² before enrollment, and<60 mL/min/1.73m² (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;
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;
The First Affiliated Hospital of Dalian Medical University
Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Collaborator