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 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT00717366
Eligibility Criteria:
Inclusion Criteria:
* Children aged 5-17 years (in Russia only: 12-17 years) with clinically stable chronic renal anemia
* Hemodialysis for greater than or equal to (\>=) 8 weeks
* Intravenous stable maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa for \>= 8 weeks before screening and with no weekly dose change \>= 25 percent (%) (increase or decrease) during the 2 weeks of screening
Exclusion Criteria:
* Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
* Red blood cell (RBC) transfusions within 8 weeks before screening or during the screening period
* Active malignant disease
* Pure red cell aplasia (PRCA) or history of PRCA
* Pregnant or lactating females
* Sexually active participants: not willing to use reliable contraception during treatment and for 90 days following the end of treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT00717366
Study Brief:
Protocol Section:
NCT00717366