Status:
TERMINATED
A Phase II Study to Assess Changes in Physical Function in Elderly Patients With Chronic Anemia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Aged
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
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...
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 ov...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00228995
Start Date
June 1 2004
End Date
September 1 2005
Last Update
June 10 2011
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