NCT00104169

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

August 29, 2008

Status Verified

August 1, 2008

Enrollment Period

2.7 years

First QC Date

February 23, 2005

Last Update Submit

August 28, 2008

Conditions

Keywords

AnemiaFrailtyEpoetinErythropoietinEPO

Outcome Measures

Primary Outcomes (1)

  • Response of Anemia

Secondary Outcomes (1)

  • To determine if there is a beneficial effect of quality of life, cognitive function, and physical function.

Interventions

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbor Hospital

Baltimore, Maryland, 21225, United States

Location

Related 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. doi: 10.1093/gerona/59.3.m249.

    PMID: 15031309BACKGROUND
  • 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.

    PMID: 15238427BACKGROUND
  • 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.

    PMID: 12893395BACKGROUND
  • 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.

    PMID: 12133021BACKGROUND
  • 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.

    PMID: 11559383BACKGROUND

MeSH Terms

Conditions

AnemiaFrailty

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • William Ershler, MD

    NIA, NIH

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 23, 2005

First Posted

February 24, 2005

Study Start

August 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

August 29, 2008

Record last verified: 2008-08

Locations