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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT00224003
Eligibility Criteria:
Inclusion Criteria:
* Male or female pediatric ESRD, Patients \>\_ 2 and \<\_ 16 years of age, whose legally authorized representative provided signed informed consent.
* Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
* Predetermined TSAT and serum Ferritin (at the screening visit).
* Receiving a stable EPO dosing regimen.
Exclusion Criteria:
* Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
* Hypersensitivity to Ferrlecit or any of its inactive components.
* High TSAT level.
* High Serum Ferritin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
16 Years
Study:
NCT00224003
Study Brief:
Protocol Section:
NCT00224003