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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT00869856
Eligibility Criteria:
Inclusion Criteria:
* Male and female CKD subjects with or without dialysis treatment
* Age \> 18 years
* Subjects under documented stable maintenance therapy with ESA, s.c. at least once per week and in accordance with the relevant SmPC, for at least 3 months with a total weekly dose of ≤ 300 IU/kg/week
* Subjects with controlled symptomatic anemia, defined as mean Hb level between 10.0 g/dL and 12.0 g/dL, based on four Hb measurements during the four-week baseline period
* Adequate iron status, serum ferritin ≥ 100 µg/L or transferrin saturation ≥ 20%
* Confirmed negative anti-EPO antibody assay from sample taken at screening visit -4
Exclusion Criteria:
* Systemic cyclosporine
* History of PRCA or aplastic anemia
* History of anti-EPO antibodies
* Uncontrolled hypertension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00869856
Study Brief:
Protocol Section:
NCT00869856