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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Chronic Anemia And Fatigue In Elderly Patients: A Randomized Double-Blind Placebo-Controlled Cross-Over Study With Epoetin Alfa.

Resource links provided by NLM:


Further study details as provided by Research and Education Foundation of Michael Reese Hospital:

Primary Outcome Measures:
  • Hemoglobin
  • Fatigue
  • Quality of Life

Secondary Outcome Measures:
  • Quality of Life
  • Mobility

Estimated Enrollment: 62
Study Start Date: January 2003
Estimated Study Completion Date: July 2005
Detailed 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337441

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
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, Illinois
Investigators
Principal Investigator: Parag Agnihotri Research and Education Foundation of Michael Reese
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00337441     History of Changes
Other Study ID Numbers: PR02-32-031
Study First Received: June 14, 2006
Last Updated: June 14, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Research and Education Foundation of Michael Reese Hospital:
Chronic Anemia
Anemia
Chronic Diseases
Elderly
Epoetin alfa
Fatigue
Quality of life
Mobility

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014