Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-30 @ 4:34 AM
Study NCT ID:
NCT00210795
Status:
TERMINATED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Organization:
Study Overview
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�)
Status:
TERMINATED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was stopped due to slow enrollment after enrolling only 12 of 80 patients over 14 months time.
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: