- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00228995
A Phase II Study to Assess Changes in Physical Function in Elderly Patients With Chronic Anemia
June 8, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Randomized, Double-blind, Placebo-controlled, Study to Assess Changes in Physical Function in Elderly Patients With Idiopathic Anemia of Aging (IAA) Receiving Epoetin Alfa (PROCRIT�)
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 (PROCRIT®) versus placebo.
Study Overview
Detailed Description
.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).
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To assess the change in physical function from baseline to end of study as measured by the Short Physical Performance Battery (SPPB) summary score.
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Secondary Outcome Measures
Outcome Measure |
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To assess: Efficacy of Procrit by achieving a target Hb of 12.5-12.9 g/dL; Change in FACT-An score; Change in Six-Minute Walk Test, Safety (Adverse Event incidence, Lab Tests, and Vitals); Cognitive function; Number and type of injuries from falls
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Study Completion (ACTUAL)
September 1, 2005
Study Registration Dates
First Submitted
September 27, 2005
First Submitted That Met QC Criteria
September 27, 2005
First Posted (ESTIMATE)
September 29, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
June 10, 2011
Last Update Submitted That Met QC Criteria
June 8, 2011
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004630
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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