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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00228995
• Other study ID #: CR004630
• Status: Terminated
• Phase: Phase 2
• First received: September 27, 2005
• Last updated: June 8, 2011
• Start date: June 2004
• Est. completion date: September 2005

Study information

• Verified date: April 2010
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aged
• Anemia
• Hemoglobins

Intervention

Drug:
• epoetin alfa

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 incidence, Lab Tests, and Vitals); Cognitive function; Number and type of injuries from falls

External Links

•   A Randomized, Double-blind, Placebo-controlled, Study to Assess Changes in Physical Function in Elderly Patients with Idiopathic Anemia of Aging (IAA) Receiving PROCRIT (Epoetin alfa)