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Idiopathic Anemia of Aging (IAA) - Article


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Anemia

General anemia


Clinical Trial: Idiopathic Anemia of Aging (IAA)

This study is currently recruiting patients.

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)

Purpose

The purpose of this trial is to examine whether Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse idiopathic anemia.

Condition Treatment or Intervention Phase
Anemia
Aging
 Drug: Epoetin Alfa
Phase II

MedlinePlus related topics:  Anemia

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Efficacy Study

Official Title: Pilot Study of Epoetin Alfa in Idiopathic Anemia of Aging (IAA)

Further Study Details: 
Primary Outcomes: Response of Anemia
Secondary Outcomes: To determine if there is a beneficial effect of quality of life, cognitive function, and physical function.
Expected Total Enrollment:  60

Study start: August 2004;  Expected completion: February 2006

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.

Eligibility

Ages Eligible for Study:  70 Years and above,  Genders Eligible for Study:  Both

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

Location and Contact Information

Pilar Strycular      410-350-3987 or 800-225-2575  Ext. 3987    strycular@grc.nia.nih.gov

Maryland
      Harbor Hospital, Baltimore,  Maryland,  21225,  United States; Recruiting
Sarah Betkey  410-350-3941 or 800-225-2572  Ext. 3941    betkeys@grc.nia.nih.gov 

Study chairs or principal investigators

Eric H. Westin, MD,  Principal Investigator,  NIA, NIH   

More Information

Publications

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.

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. Epub 2004 Jul 06.

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.

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.

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.

Study ID Numbers:  AG0014
Record last reviewed:  February 2005
Last Updated:  February 23, 2005
Record first received:  February 23, 2005
ClinicalTrials.gov Identifier:  NCT00104169
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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