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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT01114204
Eligibility Criteria:
Key Inclusion Criteria include:
1. Males and females ≥18 years of age
2. Participants with IDA defined as having:
1. Hemoglobin \<10.0 g/deciliter (dL)
2. Transferrin saturation (TSAT) \<20%
3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study
Key Exclusion Criteria include:
1. History of allergy to IV iron
2. Allergy to two or more classes of drugs
3. Participants on dialysis or with an estimated glomerular filtration rate \<30 mL/minute(min)/1.73 square meter (m\^2)
4. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
5. Hemoglobin ≤7.0 g/dL
6. Serum ferritin \>600 nanogram/mL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01114204
Study Brief:
Protocol Section:
NCT01114204