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;
Parallel
Pegmolesatide
DrugPegmolesatide Injection: Specification 1mL: 4.0mg (National Medical Products Administration Approval No. H20230020), administered once every 4 weeks
Changes of mean Hb levels from baseline in the standard medication regimen group and the optimized medication regimen group at week 24 of the treatment period.
Baseline Hb was defined as the assessments of Hb during 3days prior to first dose of the study treatment. Mean Hb levels at week 24 of the treatment period (Hb at week 24) was defined as the mean of Hb at day 168±5 of the treatment period. Changes of mean Hb levels from baseline in the standard medication regimen group and the optimized medication regimen group at week 24 of the treatment period was calculated by subtracting the baseline Hb from Hb at week 24.
Median time for two groups of Hb values to reach the target for the first time
Median time for two groups of Hb values to reach the target for the first time.
Proportion of subjects with Hb levels meeting the standard in two groups at each follow-up point
Proportion of subjects with Hb levels meeting the standard in two groups at each follow-up point.
Change of Hb from baseline at each follow-up point
Change of Hb from baseline at each follow-up point.
Change of red blood cell count from baseline at each follow-up point
Change of red blood cell count from baseline at each follow-up point.
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The First Affiliated Hospital of Dalian Medical University
Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Collaborator
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