Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT06946394
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06946394
Study Brief:
Protocol Section:
NCT06946394