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| Sponsors and Collaborators: |
Research and Education Foundation of Michael Reese Hospital Ortho Biotech Clinical Affairs, L.L.C. John H. Stroger Hospital Mercy Hospital and Medical center |
|---|---|
| Information provided by: | Research and Education Foundation of Michael Reese Hospital |
| ClinicalTrials.gov Identifier: | NCT00337441 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia |
Drug: Epoetin Alfa (drug) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Chronic Anemia And Fatigue In Elderly Patients: A Randomized Double-Blind Placebo-Controlled Cross-Over Study With Epoetin Alfa. |
| Estimated Enrollment: | 62 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | July 2005 |
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| John H. Stroger Jr. Hospital of Cook County | |
| Chicago, Illinois, United States, 60612 | |
| Mercy Hospital and Medical Center | |
| Chicago, Illinois, United States, 60616-2477 | |
| Principal Investigator: | Parag Agnihotri | Research and Education Foundation of Michael Reese |
More Information
| Study ID Numbers: | PR02-32-031 |
| Study First Received: | June 14, 2006 |
| Last Updated: | June 14, 2006 |
| ClinicalTrials.gov Identifier: | NCT00337441 |
| Health Authority: | United States: Institutional Review Board |
|
Chronic Anemia Anemia Chronic Diseases Elderly |
Epoetin alfa Fatigue Quality of life Mobility |
|
Epoetin Alfa Fatigue Hematologic Diseases |
Anemia Quality of Life Chronic Disease |
|
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |
