Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307814
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2006-03-24
Brief Title:
A Study to Evaluate PROCRIT Epoetin Alfa for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease PROMPT
Sponsor:
Ortho Biotech Products LP
Organization:
Ortho Biotech Products LP
Study Overview
Official Title:
A Randomized Open-Label Clinical Evaluation of PROCRIT Epoetin Alfa for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 effectiveness and safety of less frequent dosing of PROCRIT Epoetin alfa in patients with anemia due to Chronic Kidney Disease CKD as assessed by hemoglobin maintenance adverse events and health-related quality of life
Detailed Description:
Epoetin alfa has been widely utilized as treatment for anemia associated with Chronic Kidney Disease CKD Epoetin alfa has been shown to increase hemoglobin Hb levels by an average of 15 gdL to 2 gdL in these patients over 12 weeks Data on file Ortho Biotech Products LP This improvement in Hb levels is maintained while the patient is receiving Epoetin alfa and is associated with significant improvements in survival exercise tolerance and quality of life Literature has suggested that epoetin alfa can be given less frequently and still maintain an optimal hemoglobin while also allowing patients greater convenience This study will further confirm that less frequent dosing of epoetin alfa is safe and effective This is an open-label randomized multicenter study in patients with CKD CKD patients who are currently receiving PROCRIT therapy for at least 2 months or more and with a stable Hb 11gdL will be randomized to one of four treatment groups A stable Hemoglobin will be defined as a value that is 10 for 3 consecutive laboratory values
This study is designed to demonstrate that there is no meaningful difference in hemoglobin level with more extended dosing regimens as compared to once weekly A clinically meaningful difference is defined as a difference that is less than 10 Patients will be randomized to one of 4 treatment groups All will receive subcutaneous under the skin Epoetin alfa for a period of 16 weeks
Group 1 10000 units every week Group 2 20000 units every two weeks Group 3 30000 units every three weeks Group 4 40000 units every four weeks
This study is designed to demonstrate that there is no meaningful difference in hemoglobin level with more extended dosing regimens as compared to once weekly A clinically meaningful difference is defined as a difference that is less than 10 Patients will be randomized to one of 4 treatment groups All will receive subcutaneous under the skin Epoetin alfa for a period of 16 weeks
Group 1 10000 units every week Group 2 20000 units every two weeks Group 3 30000 units every three weeks Group 4 40000 units every four weeks
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