Phase
Condition
Anemia
Treatment
Pegmolesatide
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 usingCKD-EPI formula), with no expected renal replacement therapy plan during the studyperiod;
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
Exclusion Criteria:
Known to have hematological disorders or other diseases that cause anemia other thanchronic 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 monthsprior to randomization;
Have received oral or intravenous immunosuppressive or glucocorticoid therapy withinthe 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 thestudy period;
Assessment of cardiac function level III or IV within the first 3 days ofrandomization;
Within the first 3 days of randomization, the liver function was assessed as GradeC;
Researchers believe that subjects with any other factors that are not suitable forparticipating in this trial.