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Treatment of Chronic Anemia With Epoetin Alfa in Elderly

NCT ID: NCT00337441

Last Updated: 2006-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-07-31

Brief Summary

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The purpose of this study is to determine if chronic anemia can be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue,quality of life or mobility among elderly.

Detailed Description

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Chronic Anemia is common among elderly. Given their somewhat non-specific nature, the clinical symptoms of anemia are often difficult to attribute directly to the anemia itself. However, it is known that anemic older adults are at an increased risk of mortality, disability, higher risk of falls, poorer quality of life, worsening cognitive function, increase hospitalization risk, and increased healthcare utilization than their non-anemic counterparts.

Yet so far, there have been no treatment studies to demonstrate the benefits of correction of chronic anemia.

Epoetin Alfa (Procrit) is a manufactured form of a naturally occurring hormone that is given as an injection by a medical professional to stimulate the bone marrow's production of red blood cells.

This study is to explore, can chronic anemia be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue, quality of life or mobility among elderly.

Overall this is a 32 week treatment study.

In this study, participants with chronic anemia will receive either Epoetin alfa or placebo (saline injection) under the skin for 16 weeks. After 16 weeks the participants who were receiving epoetin will be switched to placebo and those who were receiving placebo earlier will go on now to receive epoetin alfa for 16 weeks.

At the end of 32 weeks we will compare, if epoetin alfa corrected the anemia, how individuals felt in respect to their fatigue levels, quality of life and did mobility improve during the study.

Conditions

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Anemia

Keywords

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Chronic Anemia Anemia Chronic Diseases Elderly Epoetin alfa Fatigue Quality of life Mobility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Epoetin Alfa (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 65 years of age or older Diagnosed with chronic anemia Hemoglobin level less than or equal to 11.5 g/dl Community dwelling Able to make monthly clinic visits

Exclusion Criteria

* Currently on Epoetin alfa or similar preparations Having nutritional anemia Having active cancer or received recent treatment for cancer On treatment for Kidney disease Diagnosis of dementia Inability to ambulate
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ortho Biotech Clinical Affairs, L.L.C.

INDUSTRY

Sponsor Role collaborator

Cook County Health

OTHER_GOV

Sponsor Role collaborator

Mercy Hospital and Medical Center, Illinois

OTHER

Sponsor Role collaborator

Research and Education Foundation of Michael Reese Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Parag Agnihotri

Role: PRINCIPAL_INVESTIGATOR

Research and Education Foundation of Michael Reese

Locations

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John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

Mercy Hospital and Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15238427 (View on PubMed)

Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.

Reference Type BACKGROUND
PMID: 15758012 (View on PubMed)

Penninx BW, Pahor M, Cesari M, Corsi AM, Woodman RC, Bandinelli S, Guralnik JM, Ferrucci L. Anemia is associated with disability and decreased physical performance and muscle strength in the elderly. J Am Geriatr Soc. 2004 May;52(5):719-24. doi: 10.1111/j.1532-5415.2004.52208.x.

Reference Type BACKGROUND
PMID: 15086651 (View on PubMed)

Cella D, Zagari MJ, Vandoros C, Gagnon DD, Hurtz HJ, Nortier JW. Epoetin alfa treatment results in clinically significant improvements in quality of life in anemic cancer patients when referenced to the general population. J Clin Oncol. 2003 Jan 15;21(2):366-73. doi: 10.1200/JCO.2003.02.136.

Reference Type BACKGROUND
PMID: 12525531 (View on PubMed)

Other Identifiers

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PR02-32-031

Identifier Type: -

Identifier Source: org_study_id