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

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 200 ng/mL

Sponsors

Lead Sponsor: Duke University

Collaborator: National Institute on Aging (NIA)

Source Duke University
Brief 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.

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 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.

Overall Status Terminated
Start Date May 2011
Completion Date September 2014
Primary Completion Date February 2013
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in 6 Minute Walk Test Results Baseline, 12 weeks
Secondary Outcome
Measure Time Frame
Number of Participants Who Had a Hemoglobin Increase >= 1g/dL baseline, 12 weeks
Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B Baseline, 12 weeks
Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS) Baseline, 12 weeks
Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB) baseline, 12 weeks
Change in Frailty Component Related to Fatigue/ Exhaustion baseline, 12 weeks
Change in Cognitive Outcome Measures as Determined by Speed of Processing Baseline, 12 Week
Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing Baseline, 12 week
Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory Baseline, 12 week
Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score Baseline, 12 weeks
Change in the Frailty Component as Determined by Self-reported Activity Level Baseline, 12 week
Change in Frailty Component as Determined by Grip Strength Baseline, 12 weeks
Change in Frailty Component as Determined by the 4 Meter Walk Speed Baseline, 12 weeks
Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks baseline, 12 weeks
Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin baseline, 12 weeks
Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance baseline, 12 weeks
Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance baseline, 12 weeks
Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance baseline, 12 weeks
Enrollment 19
Condition
Intervention

Intervention Type: Drug

Intervention Name: iron sucrose

Description: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter.

Arm Group Label: Immediate Intervention Group

Other Name: Venofer®

Intervention Type: Drug

Intervention Name: iron sucrose

Description: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter.

Arm Group Label: Wait List Control

Other Name: Venofer®

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

Gender: All

Minimum Age: 65 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility:
University of Illinois, Chicago | Chicago, Illinois, 60612, United States
University of Chicago Medical Center | Chicago, Illinois, 60637, United States
Johns Hopkins University Geriatrics Center | Baltimore, Maryland, 21224, United States
Case Western Reserve University Medical Center | Cleveland, Ohio, 44106, United States
Institute For Advanced Studies in Aging | Falls Church, Virginia, 22042, United States
Location Countries

United States

Verification Date

January 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Immediate Intervention Group

Type: Experimental

Description: Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.

Label: Wait List Control

Type: Experimental

Description: Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov