Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00228995
Recruitment Status : Terminated (This study was stopped due to slow enrollment after enrolling only 9 of 80 patients over 14 months time.)
First Posted : September 29, 2005
Last Update Posted : June 10, 2011
Ortho Biotech Products, L.P.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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 (PROCRIT®) versus placebo.

Condition or disease Intervention/treatment Phase
Anemia Aged Hemoglobins Drug: epoetin alfa Phase 2

Detailed 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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 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 Idiopathic Anemia of Aging (IAA) Receiving Epoetin Alfa (PROCRIT�)
Study Start Date : June 2004
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00228995

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho Biotech Products, L.P.
Layout table for investigator information
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information:
Layout table for additonal information Identifier: NCT00228995     History of Changes
Other Study ID Numbers: CR004630
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: April 2010
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Subcutaneous injection
Epoetin Alfa
Hemoglobin Level
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematologic Diseases
Epoetin Alfa