Two Different Regiments of Pegmolesatide for Anemia in Patients With Chronic Kidney Disease Not R… (NCT06946394) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Two Different Regiments of Pegmolesatide for Anemia in Patients With Chronic Kidney Disease Not Receiving Dialysis
160 participantsStarted 2025-05
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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;
What they're measuring
1
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.
Timeframe: the 24th week of treatment.
Trial details
NCT IDNCT06946394
SponsorThe First Affiliated Hospital of Dalian Medical University
✕. 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;