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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00210795

Collaborator

Ortho Biotech Products, L.P. (Industry)

Enrollment

Duration (Months)

Study Details

Study Description

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 subcutaneous doses of Epoetin alfa (PROCRITÂ®) versus placebo

Condition or Disease	Intervention/Treatment	Phase
Anemia Aged Hemoglobins	Drug: epoetin alfa	Phase 2

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 individuals over the age of 65. Physical performance and function is generally 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 PROCRIT. 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, 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo-controlled, Study to Assess Changes in Physical Function in Elderly Patients With Anemia of Chronic Disease (ACD) Receiving Epoetin Alfa (PROCRIT�)

Study Start Date :

Jun 1, 2004

Actual Study Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Incidents, Lab Tests and Vital Signs);Cognitive function; Number and type of injuries from falls []

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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 an 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho Biotech Products, L.P.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.