Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia

Not Applicable

Withdrawn

• Conditions: Anemia
• Interventions: Drug: Epoetin alfa

• Registration Number: NCT00954486
• Lead Sponsor: Stanford University

Brief Summary

The primary objective of this study is to assess the ability of epoetin alfa to raise hemoglobin (Hb) levels in elderly outpatients with unexplained anemia. The secondary objectives of this study are to assess the ability of epoetin alfa to improve physical function; cognitive function; and quality of life, and to assess the safety of epoetin alfa in the study population.

Detailed Description

Eligible subjects will be recruited out of the companion study "Anemia in the Elderly" (NCT00640172), after active participation in that study is complete. Subjects will have had a full hematologic evaluation, and unexplained anemia will have been previously defined.

Subjects will provide baseline physical function testing, including exercise testing on a treadmill and testing how far patients can walk in 6 minutes (walk test), as well as quality of life; activity level; and mental functioning.

Study visits will be weekly, and the dose level may be adjusted to achieve the target hemoglobin level within 16 weeks. Once at target, the drug will be taken for a total of 12 additional weeks. The maximum time on the study drug could be 28 weeks, and the minimum time be on the 14 weeks.

The walk tests and questionnaires will be repeated when the target hemoglobin level is reached, and when treatment is completed. The tests about quality of life, activity level, and mental functioning will be repeated at the end of treatment. Follow-up visits will be every 4 weeks for 12 weeks to check for side effects.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epoetin alfa, 10,000 units/week	Epoetin alfa	Epoetin alfa is a recombinant erythropoietin.

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin (Hb) levels	14 to 28 weeks	Measured in mg/dL

Secondary Outcome Measures

Name	Time	Method
Improve quality of life	4 to 30 weeks	Assessed by questionnaire
Improve cognitive function	16 to 30 weeks	Assessed by questionnaire
Improve physical function	4 to 30 weeks	Assessed by questionnaire

Trial Locations

Locations (3)

VAPAHCS; 🇺🇸 Palo Alto, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

The University of Chicago; 🇺🇸 Chicago, Illinois, United States