Overview

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

Status:
Terminated
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborator:
National Institute on Aging (NIA)
Treatments:
Ferric Compounds
Ferric Oxide, Saccharated
Iron
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