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

Johnson & Johnson (J&J)

Status and phase

Terminated

Phase 2

Conditions

Anemia

Hemoglobins

Aged

Treatments

Drug: epoetin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00228995

CR004630

Details and patient eligibility

About

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 (PROCRITÂ®) versus placebo.

Full 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).

Enrollment

9 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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