Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064701
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2003-07-10
Brief Title:
Comparative Study of Modified Release MR TacrolimusMycophenolate Mofetil MMF in de Novo Kidney Transplant Recipients
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase III Randomized Open-Label Comparative Multi-Center Study to Assess the Safety and Efficacy of Prograf TacrolimusMMF Modified Release MR TacrolimusMMF and Neoral CyclosporineMMF in de Novo Kidney Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2013-11
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 compare the safety and efficacy of tacrolimusmycophenolate mofetil MMF cyclosporineMMF and tacrolimus modified releaseMMF in de novo kidney transplant recipients
Detailed Description:
This was a 3 arm randomized open-label comparative multi-center study in de novo kidney transplant recipients at 60 centers in the US Canada and Brazil
The study consisted of a 1-year post-transplant efficacy and safety study with a clinical continuation phase of a minimum of 2 years or until commercial availability of tacrolimus modified release unless the Data Safety Monitoring Board or sponsor specified otherwise
The study consisted of a 1-year post-transplant efficacy and safety study with a clinical continuation phase of a minimum of 2 years or until commercial availability of tacrolimus modified release unless the Data Safety Monitoring Board or sponsor specified otherwise
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