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A Phase II Study to Assess Ch...

A Phase II Study to Assess Changes in Physical Function in Elderly Patients With Chronic Anemia

Last Updated: 2011-06-10

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-09-30

Brief Summary

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The purpose of this study is to assess changes in physical function in elderly patients (\>= 65 years of age) with chronic anemia (Hb \<= 11.0 g/dL) due to anemia of unknown cause and receiving weekly subcutaneous doses of Epoetin alfa (PROCRITÂ®) versus placebo.

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Detailed Description

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.Some elderly patients have anemia (reduction in hemoglobin level, or low red cell count) without obvious cause. Anemia occurs commonly with aging and is a frequent medical condition in individuals over the age of 65. Physical performance and function is worse in individuals who are anemic. This is a randomized, double-blind, placebo-controlled, multi-center study to assess physical function (to include falls) and fatigue in approximately 80 elderly patients with chronic anemia (anemia present for at least 3 months) and who are receiving weekly Epoetin alfa. The study will also evaluate hemoglobin levels (oxygen carrying protein in red blood cells), safety, fatigue and cognitive function. The study hypothesis is to demonstrate the study drug will be more effective in treatment of chronic anemia than placebo, resulting in the improvement of physical function and subsequent disabilities, with minimal adverse events and the study drug is generally well-tolerated. The patients will receive weekly injections of Epoetin alfa (PROCRIT®) or placebo at a starting dose of 10,000 units administered subcutaneously (under the skin).

Conditions

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Anemia Aged Hemoglobins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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epoetin alfa

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a history of chronic anemia defined as a documented Hb value of \<= 11.0 g/dL
* No active cancer
* At least 65 years of age with life expectancy of \> 6 months
* Community dwelling patients
* Patients with a Short Physical Performance (SPPB) Summary Score of 4-10 at screening and baseline
* Patients with a Mini Mental State Examination (MMSE) score \>= 24

Exclusion Criteria

* Positive stool guaiac test
* Diagnosis of multiple myeloma and/or MGUS
* History of venous thromboembolytic disease
* Previous treatment with Epoetin alfa, Darbepoetin or any form of erythropoietin recently
* Uncontrolled or severe cardiovascular disease

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers