Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia
|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|
- Change in 6 Minute Walk Test Results [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters at baseline (time of randomization) and 12 weeks after baseline (time of randomization).
- Hemoglobin Increase >/= 1g/dL [ 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 as Determined by Trail Making Test Part B [ 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 Self Reported Outcomes Measures as Reported by SF-36 Physical Component Score [ 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
- Correlation Between Baseline Serum Ferritin and Other Measures of Iron Status and the Response to IV Iron Sucrose [ Time Frame: baseline, 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 Frailty Index as Determined by Self-reported Exhaustion [ 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:||September 2014|
|Primary Completion Date:||February 2013 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309659
|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, 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|