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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT00704028
Eligibility Criteria:
Inclusion Criteria:
* Subjects ≥18 years of age and able to give informed consent
* Iron deficiency is the primary etiology of anemia
* History of intolerance or an unsatisfactory response to oral iron
* Screening Visit central laboratory Hgb ≤11 g/dL
* Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%
Exclusion Criteria:
* Previous participation in a FCM trial
* Known hypersensitivity reaction to FCM or iron dextran
* Requires dialysis for treatment of chronic kidney disease
* Current anemia not attributed to iron deficiency
* Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
* Anticipated need for surgery during the 30 day period prior to screening or during the study period
* AST or ALT greater than 1.5 times the upper limit of normal
* Received an investigational drug within 30 days of screening
* Women who are breastfeeding
* Pregnant or sexually-active females who are not willing to use an effective form of birth control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00704028
Study Brief:
Protocol Section:
NCT00704028