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

This study has been terminated.
(This study was stopped due to slow enrollment after enrolling only 9 of 80 patients over 14 months time.)
Sponsor:
Collaborator:
Ortho Biotech Products, L.P.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00228995
First received: September 27, 2005
Last updated: June 8, 2011
Last verified: April 2010

September 27, 2005
June 8, 2011
June 2004
Not Provided
To assess the change in physical function from baseline to end of study as measured by the Short Physical Performance Battery (SPPB) summary score.
Same as current
Complete list of historical versions of study NCT00228995 on ClinicalTrials.gov Archive Site
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
  • 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; and the number and type of injuries from falls
Not Provided
Not Provided
 
A Phase II Study to Assess Changes in Physical Function in Elderly Patients With Chronic Anemia
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�)

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.

.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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Anemia
  • Aged
  • Hemoglobins
Drug: epoetin alfa
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
September 2005
Not Provided

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00228995
CR004630
Yes
Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho Biotech Products, L.P.
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP