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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT03428594
Eligibility Criteria:
* Inclusion Criteria
1. Patients with 19 years of age or older
2. Patients with anemia in chronic renal failure
3. Patients who started hemodialysis more than 3 months ago and receive appropriate hemodialysis, satisfying the following criterion:
-Kt/V is ≥ 1.2 or Urea reduction ratio is ≥ 65%
4. Patients with the mean Hb levels of 10 to 12g/dl measured at the baseline and randomization visits
5. Patients with enough body iron stores who meet the following item:
-Serum ferritin ≥ 100ng/ml or Transferrin saturation ≥ 20%
6. Patients who have provided written consent to participate in the trial voluntarily
* Exclusion Criteria
1. Patients with uncontrolled hypertension
2. Patients who had hypersensitivity to erythropoietin agents
3. Patients who had known hypersensitivity to mammalian cell-derived products or diluting agents
4. Patients with history of severe cardiovascular diseases
5. Patients who have received red blood cell transfusion or hormone therapy for anemia correction within 12 weeks prior to randomization
6. Patients whose anemia is not caused by chronic renal failure or may affect anemia correction
7. Patients whose AST/ALT test results performed at screening exceed twice of normal upper limit
8. Patients who had experience of positive result in anti-erythropoietin antibody in previous treatment with erythropoiesis stimulating agent
9. Patients who have been planned to change the dialysis method
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03428594
Study Brief:
Protocol Section:
NCT03428594