A 12 Month, Multi-center, Randomized, Open-label Non-inferiority Study Comparing Safety and Efficacy of Concentration-controlled Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in de Novo Renal Transplant Recipients.

Trial Profile

A 12 Month, Multi-center, Randomized, Open-label Non-inferiority Study Comparing Safety and Efficacy of Concentration-controlled Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in de Novo Renal Transplant Recipients.

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Jun 2018

At a glance

  • Drugs Everolimus (Primary) ; Mycophenolate mofetil; Tacrolimus
  • Indications Renal transplant rejection
  • Focus Therapeutic Use
  • Sponsors Novartis
  • Most Recent Events

    • 06 Jun 2018 Results of post hoc analysis assessing everolimus trough levels around the onset of related adverse events and treatment discontinuation presented at the 2018 American Transplant Congress
    • 06 Jun 2018 Results (n=965) evaluating the effect of everolimus dosing schedules on efficacy outcomes from 2 studies (US92 and TRANSFORM) presented at the 2018 American Transplant Congress
    • 03 May 2017 Results of a post-hoc analysis investigating the influence of delayed graft function on renal function and duration of dialysis, presented at the 2017 American Transplant Congress
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