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

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

• Age ≥ 18 years old and ≤ 80 years old, gender not limited;
• Weight ≥ 45kg; Body Mass Index (BMI) ≥ 18.5kg/m^2;
• 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 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;
• During the 28days and 3days before randomization, with Hb ≥ 70g/L and < 110g/L;
• Understand the research procedure and voluntarily sign an informed consent form (ICF) in writing.

Exclusion criteria

• 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;
• Individuals with poor blood pressure control;
• C-reactive protein ≥ 30mg/L within the first 3 days of randomization;
• 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 the study period;
• Assessment of cardiac function level III or IV within the first 3 days of randomization;
• Within the first 3 days of randomization, the liver function was assessed as Grade C;
• Researchers believe that subjects with any other factors that are not suitable for participating in this trial.