Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311311
Status:
TERMINATED
Last Update Posted:
2013-09-23
First Post:
2006-04-03
Brief Title:
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Prospective Randomized Open-Label Pilot Study To Compare The Effect On Carotid Atherosclerosis Of A Tacrolimus-Based Regimen With Conversion From A Tacrolimus- To A Sirolimus-Based Regimen At 3-4 Months Post-Transplant In De Novo Renal Transplant Recipients
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
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 determine whether immunosuppression by tacrolimus mycophenolate mofetil and prednisone compared to conversion to sirolimus mycophenolate mofetil and prednisone affect the progression of atherosclerosis in renal transplant recipients
Detailed Description:
A decision to terminate the study was taken in November 2011 and a communication to that effect sent to all participating sites on November 18 All sites were asked to have patients returned to the sites and have all end of study procedures performed by Dec 31 2011
The decision to terminate this study was made following the conduct of an interim analysis which demonstrated that the study did not reach its primary endpoint The termination of this study was not driven by any safety concerns and had no impact on subject safety and well-being
The decision to terminate this study was made following the conduct of an interim analysis which demonstrated that the study did not reach its primary endpoint The termination of this study was not driven by any safety concerns and had no impact on subject safety and well-being
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