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

• Status: Terminated
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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 subcutaneous doses of Epoetin alfa (PROCRIT®) versus placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

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