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 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT01309659
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 65 years old
* Hemoglobin concentration ≥ 9.0 g/dL and \< 11.5 g/dL (women) or \< 12.7 g/dL (men)
* Unexplained anemia
* Serum ferritin level ≥ 20 and ≤ 200 ng/mL
* Able to walk without the use of a walker, motorized device or the assistance of another person.
* Able to understand and willing to provide written informed consent in the absence of dementia
* Must be able to understand and speak in English
Exclusion Criteria:
* Red blood cell transfusions within the past 3 months
* Use of erythropoiesis stimulating agents (ESA) in the past 3 months
* Intravenous Iron Infusions within the past 3 months
* Distance on baseline 6MWT (6 minute walk test) above the median for age and sex
* History of unstable angina or myocardial infarction in the past 3 months
* History of stroke or TIA (transient ischemic attack) the past 3 months
* Uncontrolled hypertension (diastolic blood pressure \> 100 mm Hg or systolic blood pressure \> 160 mm Hg on 2 separate occasions)
* Positive fecal occult blood test within the screening period
* Elevated AST (aspartate aminotransferase) or ALT (alanine aminotransferase) ≥ 2x upper limit of normal
* Documented anaphylactic reaction to iron sucrose infusion in the past
* Subjects initiated on oral iron supplementation within the last 6 weeks, or those initiated on oral iron within the last 3 months who have had at least a one gram/dL improvement in Hb since starting oral iron supplementation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01309659
Study Brief:
Protocol Section:
NCT01309659