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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00228995
Other study ID # CR004630
Secondary ID
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
Est. primary completion date
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


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
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