Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189839
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2005-09-13
Brief Title:
A Study to Evaluate the Safety and Efficacy of FK506E MR4 in Patients Undergoing Primary Kidney Transplantation
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Multicentre Randomised Double Blind Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E MR4 Versus Tacrolimus FK506 in Combination With MMF Cellcept and Steroids in Patients Undergoing Kidney Transplantation
Status:
COMPLETED
Status Verified Date:
2014-07
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 and to compare the efficacy and safety of a triple modified release tacrolimus FK506E MR4 MMF steroid regimen with a triple standard tacrolimus FK506 MMF steroid regimen in patients undergoing kidney transplantation It shall be demonstrated that FK506E MR4 is non-inferior to FK506 with regards to the primary endpoint
Detailed Description:
A multicentre 11 randomised double blind double dummy two arm parallel group phase III study comparing a triple modified release tacrolimus FK506E MR4 MMF steroid regimen with a triple standard tacrolimus FK506 MMF steroid regimen
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