Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240734
Status:
TERMINATED
Last Update Posted:
2011-06-10
First Post:
2005-10-14
Brief Title:
Treatment of Anemia in Diabetic Subjects With CKD
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was stopped for slow enrollment after enrolling only 11 of 180 patients in six 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 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 gramdeciliter increase from baseline by Week 17
Detailed Description:
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 11 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 gramdeciliter 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 10000 U 10 mL or matching placebo The maximum dose administered is 20000 U 20 mL
Study Oversight
Has Oversight DMC:
None
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?:
None