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Idiopathic Anemia of Aging (IAA)

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ClinicalTrials.gov Identifier: NCT00104169
Recruitment Status : Terminated (No subject accrual)
First Posted : February 24, 2005
Last Update Posted : August 29, 2008
Sponsor:
Information provided by:
National Institute on Aging (NIA)

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.

Condition or disease Intervention/treatment Phase
Anemia Aging Drug: Epoetin Alfa Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Pilot Study of Epoetin Alfa in Idiopathic Anemia of Aging (IAA)
Study Start Date : August 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources




Primary Outcome Measures :
  1. Response of Anemia

Secondary Outcome Measures :
  1. To determine if there is a beneficial effect of quality of life, cognitive function, and physical function.


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104169


Locations
United States, Maryland
Harbor Hospital
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: William Ershler, MD NIA, NIH