Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 200 ng/mL|
- Improvement in 6 Minute Walk Test Results [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To determine whether the administration of 1000 mg of IV iron sucrose to older adults with UAE and a serum ferritin between 20 and 100 ng/mL leads to improvement in 6MWT results. The primary endpoint is change in 6MWT distances from baseline to 12 weeks. This will be assessed at baseline then at 6 weeks, 12 weeks, 18 weeks, and 24 weeks. In the wait list control group, measures at 12 weeks prior initiating IV iron are outcomes for the control group and they are also treated as the baseline for IV iron treatment at week 12 where treatment visit 1 coincides with the week 12 visit.
- Change in hemoglobin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To assess the efficacy of IV iron sucrose in improving Hb by at least 1 g/dL
- Frequency of clinical events and reportable events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]All clinical events and reportable events will be tabulated and ordered by decreasing frequency for all subjects by randomized groups as a measure of safety and tolerability of IV iron sucrose in older adults
- Change in cognitive outcome measures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on the Trail Making Test (TMT) Part A and B as measured by seconds per completed circle, and the Cogstate yield 9 test scores that will be used in the analyses of the secondary cognitive outcomes
- Change in serum ferritin in relation to change in hemoglobin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Correlation between baseline serum ferritin and other measures of iron status (transferrin saturation, soluble transferrin receptor, soluble receptor/log ferritin) and response to IV iron sucrose by assessing the relationship between the baseline iron status and the change in HB from baseline to 12 weeks
- Change in self reported outcomes measures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To quantify the impact of anemia treatment by IV iron sucrose on self-reported outcomes measures by change in SF36 8 scale scores and the physical component score and FACIT-AN 5 subscale scores, a trial outcome index and a total score
- Change in frailty index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty index as measured by change in self-reported exhaustion score, self-reported activity level score, Grip-strength (kgs) and 4 meter walk speed (meters/sec)
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Immediate Intervention Group
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.
Drug: iron sucrose
Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter.
Other Name: Venofer®
Experimental: Wait List Control
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
Drug: iron sucrose
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.
Other Name: Venofer®
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.
|United States, California|
|UCLA Medical Center|
|Los Angeles, California, United States, 90095|
|Stanford University Medical Center|
|Palo Alto, California, United States, 94305|
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|University of Illinois, Chicago|
|Chicago, Illinois, United States, 60612|
|United States, Maryland|
|Johns Hopkins University Geriatrics Center|
|Baltimore, Maryland, United States, 21224|
|United States, Ohio|
|Case Western Reserve University Medical Center|
|Cleveland, Ohio, United States, 44106|
|United States, Utah|
|University of Utah School of Medicine|
|Salt Lake City, Utah, United States, 84132|
|United States, Virginia|
|Institute For Advanced Studies in Aging|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Elizabeth Price, MD||Stanford University MC|
|Study Chair:||Stanley Schrier, MD||Stanford University|
|Principal Investigator:||Andrew Artz, MD||University of Chicago|