Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia

Stopped early · Phase 2

Conditions studied: Anemia, Unexplained Anemia (UAE)

In brief

The purpose of this study is to determine whether treatment of unexplained anemia in older adults with a short course of weekly intravenous iron infusions can improve physical activity and therefore quality of life.

Key facts

Study ID

NCT01309659

Run by

Duke University

People needed

19

Starts

2011-05-01

Expected to finish

2014-09-01

Last updated by the study team

2016-02-05

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Illinois, Chicago — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Johns Hopkins University Geriatrics Center — Baltimore, Maryland, United States
• Case Western Reserve University Medical Center — Cleveland, Ohio, United States
• Institute For Advanced Studies in Aging — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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