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

There is a tremendous morbidity and mortality associated with anemia in the elderly and the
increasing proportion of elderly adults underscores the population's attributable risk of
anemia. As a potentially modifiable factor, an urgent need exists to delineate the impact of
anemia correction in the elderly. The Partnership for Anemia: Clinical and Translational
Trials in the Elderly (PACTTE) consortium has been created to focus on treatment strategies
for anemia in elderly patients. The data presented in this protocol provides a compelling
rationale to evaluate the impact of a well-tolerated IV iron preparation in community
dwelling older anemic adults with intermediate serum ferritin values.

Subjects will be 65 years or older adults with unexplained anemia and a serum ferritin
between 20 and 200 ng/mL.

Subjects will be randomized on a 1:1 basis to either receive a 5 week course of treatment
with intravenous iron immediately or to a waitlist control group who will receive treatment
with intravenous iron following a 12 week observation period. Both groups will ultimately
receive 200mg of intravenous iron sucrose weekly for 5 weeks to determine if this can lead
to improvement in 6 Minute Walk Test results. The primary endpoint is change in 6 Minute
Walk Test distances from baseline to 12 weeks. The procedures in this protocol will include
the use of outcomes tools that have been selected for their ability to show improvement in
quality of life in this patient population. Blood samples will also be collected for
analysis both at the local lab (safety tests - eg hemoglobin or Hb) or at a central lab for
research purposes.

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