Anemia Clinical Trial
Official title:
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | September 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Ortho Biotech Products, L.P. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the change in physical function from baseline to end of study as measured by the Short Physical Performance Battery (SPPB) summary score. | |||
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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