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 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT01151592
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects \> or = to 18 years of age
* Determined by treating physician to have chronic kidney disease and require a course of intravenous iron
* Subject did not tolerate an intravenous iron containing a dextran or Ferumoxytol within the last year
* Subjects with hemodialysis-dependent or peritoneal dialysis chronic kidney disease should be receiving an erythropoiesis stimulating agent (ESA) as per the iron sucrose package insert
Exclusion Criteria:
* Known history of hypersensitivity or significant intolerance to iron sucrose
* Evidence of iron overload
* Hemochromatosis or other iron storage disorders
* Received an investigational drug within 30 days of screening
* Any other laboratory abnormality, medical condition or psychiatric disorder which would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
* Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01151592
Study Brief:
Protocol Section:
NCT01151592