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

Condition(s) targeted: Anemia; Unexplained Anemia

Intervention: iron sucrose (Drug); iron sucrose (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Elizabeth Price, MD, Principal Investigator, Affiliation: Stanford University MC
Stanley Schrier, MD, Study Chair, Affiliation: Stanford University
Andrew Artz, MD, Principal Investigator, Affiliation: University of Chicago

Overall contact:
Kerstin McHutchison, RN, Phone: 919 668 8021, Email: kerstin.newland@duke.edu

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.

Official title: A Randomized, Open-Label, Wait-list Control Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia and a Serum Ferritin Between 20 and 100 ng/mL

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Improvement in 6 Minute Walk Test Results

Secondary outcome:

Change in hemoglobin

Safety of IV iron sucrose in older adults

Change in cognitive outcome measures

Correlation of iron status and response to IV iron sucrose

Change in self reported outcomes measures

Change in frailty index

Detailed description: 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 100 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 Hb) or at a central lab for research

purposes.

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age ≥ 65 years old

- Hb concentration ≥ 9. 0 g/dL and < 11. 5 g/dL (women) or < 12. 7 g/dL (men)

- Unexplained anemia

- Serum ferritin level ≥ 20 and ≤ 100 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 above the median for age and sex

- History of unstable angina or myocardial infarction in the past 3 months

- History of stroke or TIA in 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 (SGOT) or ALT (SGPT) ≥ 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

Kerstin McHutchison, RN, Phone: 919 668 8021, Email: kerstin.newland@duke.edu

UCLA Medical Center, Los Angeles, California 90095, United States; Recruiting
Karina Ramirez, Phone: 310-267-0845, Email: kramirez@mednet.ucla.edu
Heather McCreath, PhD, Phone: 310-267-0848, Email: hmccreath@mednet.ucla.edu
David Reuben, MD, Principal Investigator

Stanford University Medical Center, Palo Alto, California 94305, United States; Recruiting
Angela Lai, Phone: 650-736-1836, Email: ahlai@stanford.edu
Stanley Schrier, MD, Sub-Investigator
Elizabeth Price, MD, Principal Investigator

University of Chicago Medical Center, Chicago, Illinois 60637, United States; Recruiting
Peggy Green, Phone: 773-702-0267, Email: mgreen@medicine.bsd.uchicago.edu
Andrew Artz, MD, Principal Investigator

Johns Hopkins University Geriatrics Center, Baltimore, Maryland 21224, United States; Recruiting
Jeremy Walston, MD, Phone: 410-550-1003
Jeremy Walston, MD, Principal Investigator
Luigi Ferrucci, MD, Sub-Investigator

Case Western Reserve University Medical Center, Cleveland, Ohio 44106, United States; Recruiting
Matthew Nelson, Phone: 216-286-6535, Email: matthew.nelson@UHhospitals.org
Nathan Berger, MD, Principal Investigator

University of Utah School of Medicine, Salt Lake City, Utah 84132, United States; Recruiting
Jasmine Leigh, Phone: 801-581-3707, Email: jasmine.lee@hsc.utah.edu
Josef Prchal, MD, Principal Investigator

PACTTE Consortium website

Starting date: May 2011
Last updated: September 29, 2011