Idiopathic Anemia of Aging (IAA)

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00104169
• Other study ID #: AG0014
• Status: Terminated
• Phase: Phase 2
• First received: February 23, 2005
• Last updated: August 28, 2008
• Start date: August 2004
• Est. completion date: May 2007

Study information

• Verified date: August 2008
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Anemia

Intervention

Drug:
• Epoetin Alfa

Locations

Country	Name	City	State
United States	Harbor Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. Epub 2004 Jul 6. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response of Anemia
Secondary	To determine if there is a beneficial effect of quality of life, cognitive function, and physical function.