NCT00337441

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 1, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
Last Updated

June 16, 2006

Status Verified

June 1, 2006

First QC Date

June 14, 2006

Last Update Submit

June 14, 2006

Conditions

Anemia

Keywords

Chronic AnemiaAnemiaChronic DiseasesElderlyEpoetin alfaFatigueQuality of lifeMobility

Outcome Measures

Primary Outcomes (3)

  • Hemoglobin

  • Fatigue

  • Quality of Life

Secondary Outcomes (2)

  • Quality of Life

  • Mobility

Interventions

Epoetin Alfa (drug)DRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Mercy Hospital and Medical Center

Chicago, Illinois, 60616-2477, United States

Location

Related Publications (4)

  • 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

  • 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.

    PMID: 15758012BACKGROUND

  • 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.

    PMID: 15086651BACKGROUND

  • 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.

    PMID: 12525531BACKGROUND

MeSH Terms

Conditions

AnemiaChronic DiseaseFatigue

Interventions

Epoetin AlfaPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Parag Agnihotri

    Research and Education Foundation of Michael Reese

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 16, 2006

Study Start

January 1, 2003

Study Completion

July 1, 2005

Last Updated

June 16, 2006

Record last verified: 2006-06

Locations

US(2)