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Treatment of Chronic Anemia With Epoetin Alfa in Elderly

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Research and Education Foundation of Michael Reese Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Ortho Biotech Clinical Affairs, L.L.C.
John H. Stroger Hospital
Mercy Hospital and Medical Center, Illinois
Information provided by:
Research and Education Foundation of Michael Reese Hospital
ClinicalTrials.gov Identifier:
NCT00337441
First received: June 14, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted

June 14, 2006
June 14, 2006
January 2003
Not Provided
  • Hemoglobin
  • Fatigue
  • Quality of Life
Same as current
No Changes Posted
  • Quality of Life
  • Mobility
Same as current
Not Provided
Not Provided
 
Treatment of Chronic Anemia With Epoetin Alfa in Elderly
Chronic Anemia And Fatigue In Elderly Patients: A Randomized Double-Blind Placebo-Controlled Cross-Over Study With Epoetin Alfa.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Anemia
Drug: Epoetin Alfa (drug)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
62
July 2005
Not Provided

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00337441
PR02-32-031
Not Provided
Not Provided
Research and Education Foundation of Michael Reese Hospital
  • Ortho Biotech Clinical Affairs, L.L.C.
  • John H. Stroger Hospital
  • Mercy Hospital and Medical Center, Illinois
Principal Investigator: Parag Agnihotri Research and Education Foundation of Michael Reese
Research and Education Foundation of Michael Reese Hospital
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP