Treatment of Anemia in Diabetic Subjects With CKD
The purpose of this study is to compare the proportion of subjects receiving either Epoetin alfa (PROCRITÂ®) or placebo who are able to achieve a hemoglobin response, defined by at least a 1 gram/deciliter increase from baseline by Week 17.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo-Controlled Study Evaluating Weekly Epoetin Alfa (PROCRIT�) Administration on Hemoglobin Response and Safety in Diabetic Subjects With the Anemia of Chronic Kidney Disease (CKD)|
- The primary endpoint is the hemoglobin response rate, defined as the proportion of subjects who achieve at least a 1 gram per deciliter hemoglobin increase from baseline by Week 17.
- The secondary endpoints include evaluation of health-related quality life, hemoglobin change over time, time to hemoglobin response, and transfusion utilization.
|Study Start Date:||March 2005|
|Study Completion Date:||September 2005|
This is a prospective, randomized, double blind, placebo controlled, multi-center study in diabetic subjects with the anemia of chronic kidney disease. Subjects will be randomly assigned in a 1:1 ratio to receive either Epoetin alfa (PROCRIT®) or matching placebo for sixteen weeks. Epoetin alfa (PROCRIT®) is indicated for the treatment of anemia associated with chronic renal failure (pre-dialysis), non-myeloid malignancies receiving chemotherapy, in HIV-infected subjects receiving zidovudine therapy, and in anemic subjects undergoing elective non-cardiac, non-vascular surgery to reduce the need for allogenic blood transfusion during high-volume blood loss procedures. This study is being undertaken to assess, under well-controlled conditions, the effect of weekly Epoetin alfa (PROCRIT®) treatment on hemoglobin response in diabetic subjects with the anemia of chronic kidney disease. The study hypothesis is that weekly PROCRIT treatment will be effective in achieving a hemoglobin response than placebo, where hemoglobin response is defined by at least a 1 gram/deciliter increase from baseline by Week 17. The subjects are administered study drug (PROCRIT® or matching placebo) once weekly by subcutaneous injection by a health care professional for 16 weeks. The initial dose of study drug is either PROCRIT® 10,000 U (1.0 mL) or matching placebo. The maximum dose administered is 20,000 U (2.0 mL).
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|