Idiopathic Anemia of Aging (IAA)

This study has been terminated.
(No subject accrual)
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00104169
First received: February 23, 2005
Last updated: August 28, 2008
Last verified: August 2008
  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 Intervention Phase
Anemia
Aging
Drug: Epoetin Alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
Official Title: Pilot Study of Epoetin Alfa in Idiopathic Anemia of Aging (IAA)

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

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.

Enrollment: 0
Study Start Date: August 2004
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
  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: NCT00104169

Locations
United States, Maryland
Harbor Hospital
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Investigators
Principal Investigator: William Ershler, MD NIA, NIH
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00104169     History of Changes
Other Study ID Numbers: AG0014
Study First Received: February 23, 2005
Last Updated: August 28, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Anemia
Frailty
Epoetin
Erythropoietin
EPO

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

ClinicalTrials.gov processed this record on October 22, 2014