Status and phase
Conditions
Treatments
About
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.
Full description
A multicentre, 1:1 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
699 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal