Status:
NOT_YET_RECRUITING
Two Different Regiments of Pegmolesatide for Anemia in Patients With Chronic Kidney Disease Not Receiving Dialysis
Lead Sponsor:
The First Affiliated Hospital of Dalian Medical University
Collaborating Sponsors:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Renal Anemia in Non-dialysis Chronic Kidney Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06946394
Start Date
May 1 2025
End Date
November 1 2026
Last Update
April 27 2025
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