Treatment of Chronic Anemia With Epoetin Alfa in Elderly
|ClinicalTrials.gov Identifier: NCT00337441|
Recruitment Status : Unknown
Verified June 2006 by Research and Education Foundation of Michael Reese Hospital.
Recruitment status was: Active, not recruiting
First Posted : June 16, 2006
Last Update Posted : June 16, 2006
|First Submitted Date ICMJE||June 14, 2006|
|First Posted Date ICMJE||June 16, 2006|
|Last Update Posted Date||June 16, 2006|
|Study Start Date ICMJE||January 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Treatment of Chronic Anemia With Epoetin Alfa in Elderly|
|Official Title ICMJE||Chronic Anemia And Fatigue In Elderly Patients: A Randomized Double-Blind Placebo-Controlled Cross-Over Study With Epoetin Alfa.|
|Brief Summary||The purpose of this study is to determine if chronic anemia can be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue,quality of life or mobility among elderly.|
Chronic Anemia is common among elderly. Given their somewhat non-specific nature, the clinical symptoms of anemia are often difficult to attribute directly to the anemia itself. However, it is known that anemic older adults are at an increased risk of mortality, disability, higher risk of falls, poorer quality of life, worsening cognitive function, increase hospitalization risk, and increased healthcare utilization than their non-anemic counterparts.
Yet so far, there have been no treatment studies to demonstrate the benefits of correction of chronic anemia.
Epoetin Alfa (Procrit) is a manufactured form of a naturally occurring hormone that is given as an injection by a medical professional to stimulate the bone marrow's production of red blood cells.
This study is to explore, can chronic anemia be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue, quality of life or mobility among elderly.
Overall this is a 32 week treatment study.
In this study, participants with chronic anemia will receive either Epoetin alfa or placebo (saline injection) under the skin for 16 weeks. After 16 weeks the participants who were receiving epoetin will be switched to placebo and those who were receiving placebo earlier will go on now to receive epoetin alfa for 16 weeks.
At the end of 32 weeks we will compare, if epoetin alfa corrected the anemia, how individuals felt in respect to their fatigue levels, quality of life and did mobility improve during the study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Epoetin Alfa (drug)|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||July 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||65 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00337441|
|Other Study ID Numbers ICMJE||PR02-32-031|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Research and Education Foundation of Michael Reese Hospital|
|PRS Account||Research and Education Foundation of Michael Reese Hospital|
|Verification Date||June 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP