Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113269
Status:
COMPLETED
Last Update Posted:
2011-08-11
First Post:
2005-06-07
Brief Title:
SafetyEfficacy of Induction Agents With Tacrolimus MMF and Rapid Steroid Withdrawal in Renal Transplant Recipients
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
Phase 4 Randomized Open-label Comparative Multicenter Study to Assess the Safety and Efficacy of Induction Agents Alemtuzumab Basiliximab or Rabbit Anti-thymocyte Globulin in Combination With Tacrolimus MMF and a Rapid Steroid Withdrawal in Renal Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2011-08
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:
INTAC
Brief Summary:
The purpose of this study is to compare the safety and efficacy of different induction agents alemtuzumab basiliximab or rabbit anti-thymocyte globulin in renal transplant recipients treated with tacrolimus mycophenolate mofetil MMF and a rapid steroid withdrawal
Detailed Description:
A 2 arm 1 Active 1 Active Control study is to compare the safety and efficacy of different induction agents alemtuzumab basiliximab or rabbit anti-thymocyte globulin in renal transplant recipients treated with tacrolimus MMF and a rapid steroid withdrawal
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