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 a chronic condition that causes anemia (reduction in hemoglobin level, or low red cell count). Anemia occurs commonly with aging and is a frequent medical condition in indiv...
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 an 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 :
October 1 2005
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00210795
Start Date
June 1 2004
End Date
October 1 2005
Last Update
June 10 2011
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