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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Nov 2017

At a glance

  • Drugs Tacrolimus (Primary)
  • Indications Renal transplant rejection
  • Focus Therapeutic Use
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 01 Nov 2017 Results of pooled analysis of NCT00189839 and NCT00717470 trials comparing outcomes with prolonged-release tacrolimus and immediate-release tacrolimus published in the Transplantation Proceedings
    • 07 Jan 2011 Primary endpoint 'Acute-transplant-rejection' has not been met
    • 01 Jan 2008 Status change from in progress to completed, from clinicaltrials.gov record.
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