two different regiments of pegmolesatide for anemia in patients with chronic kidney disease not receiving dialysis

Conditions: Renal Anemia in Non-dialysis Chronic Kidney Disease

Summary: 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.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old and ≤ 80 years old, gender not limited; 2. weight ≥ 45kg; body mass index (bmi) ≥ 18.5kg/m\^2; 3. 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; 4. rhuepo or hif-phi should be used for ≥ 4 weeks and ≤ 12 weeks; 5. during the 28days and 3days before randomization, with hb ≥ 70g/l and \< 110g/l; 6. understand the research procedure and voluntarily sign an informed consent form (icf) in writing. 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. have received oral or intravenous immunosuppressive or glucocorticoid therapy within the 12 weeks prior to randomization; 5. individuals with poor blood pressure control; 6. c-reactive protein ≥ 30mg/l within the first 3 days of randomization; 7. 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; 8. assessment of cardiac function level iii or iv within the first 3 days of randomization; 9. within the first 3 days of randomization, the liver function was assessed as grade c; 10. researchers believe that subjects with any other factors that are not suitable for participating in this trial.

Keywords: anemia