Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210743
Status:
COMPLETED
Last Update Posted:
2011-05-23
First Post:
2005-09-13
Brief Title:
Alternate Dosing - Initiation of Every 2 Week Epoetin Alfa PROCRIT in the Treatment of Anemia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Open-Label Clinical Evaluation of the Initiation of Every 2 Week Epoetin Alfa PROCRITin the Treatment of Subjects With the Anemia of Chronic Kidney Disease CKD
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 evaluate the hemoglobin response rate in subjects with anemia associated with chronic kidney failure after receiving epoetin alfa PROCRITÂ every 2 weeks
Detailed Description:
This is a prospective study in non-dialysis subjects with anemia associated with chronic kidney disease Subjects will be enrolled from multiple centers in the United States The primary objective of the study is to evaluate hemoglobin response rate The secondary objectives include evaluating the time to when hemoglobin responds indicated by the results of the hemoglobin blood levels the change in hemoglobin over time the transfusion requirements and change in quality of life measurements These measurements asks for the subjects views about how one feels activity and energy level etc The subjects are administered study drug every 2 weeks through Study Week 27 unless dosing is held or the subject withdraws from the study Each injection of study drug should not exceed 1 ml in volume
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