Idiopathic Anemia of Aging (IAA)
Primary Purpose
Anemia, Aging
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Epoetin Alfa
Sponsored by

About this trial
This is an interventional treatment trial for Anemia focused on measuring Anemia, Frailty, Epoetin, Erythropoietin, EPO
Eligibility Criteria
Inclusion Criteria: 70 years of age or older Diagnosed with anemia Hemoglobin level less than or equal to 11 Able to perform most activities of daily living without restriction Exclusion Criteria: History of serious heart, liver or kidney disease Cancer treated within the last year except for skin cancer (excluding melanoma) Problems with your immune system Received Epoetin Alfa within the last year
Sites / Locations
- Harbor Hospital
Outcomes
Primary Outcome Measures
Response of Anemia
Secondary Outcome Measures
To determine if there is a beneficial effect of quality of life, cognitive function, and physical function.
Full Information
NCT ID
NCT00104169
First Posted
February 23, 2005
Last Updated
August 28, 2008
Sponsor
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT00104169
Brief Title
Idiopathic Anemia of Aging (IAA)
Official Title
Pilot Study of Epoetin Alfa in Idiopathic Anemia of Aging (IAA)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Terminated
Why Stopped
No subject accrual
Study Start Date
August 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Aging (NIA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this trial is to examine whether Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse idiopathic anemia.
Detailed Description
As individuals become older, the frequency of anemia increases. While the cause of anemia in many cases can be determined and corrected, in a number of individuals there is no correctable cause found and the patient must live with their anemia. This is known as idiopathic anemia, and can have serious consequences for the individual. Numerous studies have demonstrated that anemia is associated with loss of energy and stamina, causing individuals to decrease their activities, which adversely affects both their sense of well-being as well as their physical strength. Losses in these areas are associated with the clinical manifestations of frailty.
The current pilot study will examine whether or not administration of Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse this type of anemia. We will examine the consequences of reversing the anemia in terms of physical strength and function, cardiovascular function and sense of well-being and mental function.
In this study, individuals with anemia will be treated for six months with Epoetin Alfa following the correction of their anemia and measurements done to evaluate physical strength, performance, cardiac, mental and kidney function. At the end of treatment, individuals will be followed for an additional six months to determine whether the anemia recurs and physical function decreases.
Participation in this study is voluntary. All testing and medication received are free to the participant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Aging
Keywords
Anemia, Frailty, Epoetin, Erythropoietin, EPO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Epoetin Alfa
Primary Outcome Measure Information:
Title
Response of Anemia
Secondary Outcome Measure Information:
Title
To determine if there is a beneficial effect of quality of life, cognitive function, and physical function.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
70 years of age or older
Diagnosed with anemia
Hemoglobin level less than or equal to 11
Able to perform most activities of daily living without restriction
Exclusion Criteria:
History of serious heart, liver or kidney disease
Cancer treated within the last year except for skin cancer (excluding melanoma)
Problems with your immune system
Received Epoetin Alfa within the last year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Ershler, MD
Organizational Affiliation
NIA, NIH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harbor Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15031309
Citation
Cesari M, Penninx BW, Lauretani F, Russo CR, Carter C, Bandinelli S, Atkinson H, Onder G, Pahor M, Ferrucci L. Hemoglobin levels and skeletal muscle: results from the InCHIANTI study. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):249-54. doi: 10.1093/gerona/59.3.m249.
Results Reference
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PubMed Identifier
15238427
Citation
Guralnik JM, Eisenstaedt RS, Ferrucci L, Klein HG, Woodman RC. Prevalence of anemia in persons 65 years and older in the United States: evidence for a high rate of unexplained anemia. Blood. 2004 Oct 15;104(8):2263-8. doi: 10.1182/blood-2004-05-1812. Epub 2004 Jul 6.
Results Reference
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PubMed Identifier
12893395
Citation
Penninx BW, Guralnik JM, Onder G, Ferrucci L, Wallace RB, Pahor M. Anemia and decline in physical performance among older persons. Am J Med. 2003 Aug 1;115(2):104-10. doi: 10.1016/s0002-9343(03)00263-8.
Results Reference
background
PubMed Identifier
12133021
Citation
Chaves PH, Ashar B, Guralnik JM, Fried LP. Looking at the relationship between hemoglobin concentration and prevalent mobility difficulty in older women. Should the criteria currently used to define anemia in older people be reevaluated? J Am Geriatr Soc. 2002 Jul;50(7):1257-64. doi: 10.1046/j.1532-5415.2002.50313.x.
Results Reference
background
PubMed Identifier
11559383
Citation
Kikuchi M, Inagaki T, Shinagawa N. Five-year survival of older people with anemia: variation with hemoglobin concentration. J Am Geriatr Soc. 2001 Sep;49(9):1226-8. doi: 10.1046/j.1532-5415.2001.49241.x.
Results Reference
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Idiopathic Anemia of Aging (IAA)
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