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:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT07136792
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18-75 years, regardless of gender;
2. Body weight ≥ 45 kg, and body mass index (BMI) ≥ 18.5 kg/m²;
3. Diagnosis of chronic renal failure, and having undergone a stable regimen of peritoneal dialysis or hemodialysis for at least 12 weeks prior to enrollment (with stable hemofiltration at a frequency of every 2 or 4 weeks if applicable). Stable dialysis frequency and no plans to change the dialysis modality during the trial;
4. An up to standard dialysis adequacy testing result before randomization: spKt/V ≥ 1.2 for hemodialysis, Kt/V ≥ 1.7 for peritoneal dialysis;
5. Roxadustat dose ≤ 360 mg/week within 4 weeks before randomization, with stable dose; \[Stable dose is defined as: (the maximum weekly dose within 4 weeks before randomization - the average weekly dose within 4 weeks before randomization) ÷ the maximum weekly dose within 4 weeks before randomization ≤ 30%\];
6. Two pre-dialysis HB test values within 4 weeks before randomization of 8.0 - 12.0 g/dl, with an absolute difference between the two Hb values ≤ 1.3 g/dl, and an interval of ≥ 7 days between the two HB tests;
7. Serum ferritin level ≥ 100 μg/L and transferrin saturation (TAST) ≥ 20% at the time of testing before randomization, serum folate ≥ the lower limit of normal, and vitamin B12 ≥ the lower limit of normal;
8. Understanding of the study procedures and voluntary signing of the written informed consent form.
Exclusion Criteria:
1. Known autoimmune diseases, hematologic disorders (including congenital and acquired conditions such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndrome, hemolytic anemia, and coagulation disorders), or other causes of anemia apart from CKD (such as gastrointestinal bleeding or hookworm disease).
2. Confirmed diagnosis of acquired immunodeficiency syndrome (AIDS), syphilis, or tuberculosis and currently undergoing treatment.
3. Known allergy to iron agents or polyethylene glycol molecules.
4. Treatment history with ESAs in combination with HIF-PHIs drugs within 8 weeks prior to randomization.
5. Underwent red blood cell or whole blood transfusion within 12 weeks prior to randomization.
6. Poorly controlled blood pressure (uncontrolled hypertension is defined as: during the screening period, systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg in two or more blood pressure measurements, or although the blood pressure values are below the aforementioned criteria, the investigator deems it necessary to adjust antihypertensive medications).
7. Active hepatitis or any of the following abnormal test results during the screening period (ALT ≥ 2 times the upper limit of normal, AST ≥ 2 times the upper limit of normal, DBIL ≥ 2 times the upper limit of normal, serum albumin \< 2.5 g/dl).
8. Participants judged by the investigator to have uncontrolled or symptomatic secondary hyperparathyroidism, or those with blood iPTH \> 800 pg/mL during the screening period.
9. C-reactive protein ≥ 30 mg/L during the screening period.
10. Cardiac function assessed as NYHA Class III or IV during the screening period.
11. Pregnant or breastfeeding women, or those planning to become pregnant during the study period.
12. Participants who plan to undergo kidney transplantation during the trial period or have already been kidney donors, or those who plan to undergo elective surgery during the trial period.
13. Participants deemed by the investigator to have any other factors that make them unsuitable for participation in this trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07136792
Study Brief:
Protocol Section:
NCT07136792