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.
Aged ≥18 years and ≤80 years, regardless of gender;
Body weight ≥45 kg; Body Mass Index (BMI) ≥18.5 kg/m²;
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;
Hemoglobin (Hb) level measured within 7 days before randomization ≥70 g/L and < 110 g/L;
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;
Having received or planned to receive anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization or during the study treatment period;
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 (110-130g/L) for the first time
Median time for two groups of Hb values to reach the target (110-130g/L) for the first time.
The proportion of subjects with Hb average values ranging from 100-120 g/L and 110-130 g/L at each follow-up point during the treatment period in the two groups
The proportion of subjects with Hb average values ranging from 100-120 g/L and 110-130 g/L at each follow-up point during the treatment period in the two groups
Change of Hb from baseline at each follow-up point
Change of Hb from baseline at each follow-up point.
The absolute values of Hb levels at each follow-up point in the two groups during the treatment period
The absolute values of Hb levels at each follow-up point in the two groups during the treatment period
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The First Affiliated Hospital of Dalian Medical University
Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Collaborator
