Overview

This trial is active, not recruiting.

Condition anemia
Treatment epoetin alfa (drug)
Phase phase 2
Sponsor Research and Education Foundation of Michael Reese Hospital
Collaborator Ortho Biotech Clinical Affairs, L.L.C.
Start date January 2003
End date July 2005
Trial size 62 participants
Trial identifier NCT00337441, PR02-32-031

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Hemoglobin
time frame:
Fatigue
time frame:
Quality of Life
time frame:

Secondary Outcomes

Measure
Quality of Life
time frame:
Mobility
time frame:

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: - 65 years of age or older Diagnosed with chronic anemia Hemoglobin level less than or equal to 11.5 g/dl Community dwelling Able to make monthly clinic visits Exclusion Criteria: - Currently on Epoetin alfa or similar preparations Having nutritional anemia Having active cancer or received recent treatment for cancer On treatment for Kidney disease Diagnosis of dementia Inability to ambulate

Additional Information

Official title Chronic Anemia And Fatigue In Elderly Patients: A Randomized Double-Blind Placebo-Controlled Cross-Over Study With Epoetin Alfa.
Principal investigator Parag Agnihotri
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2006.
Information provided to ClinicalTrials.gov by Research and Education Foundation of Michael Reese Hospital.