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: 03 May 2017

At a glance

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

    • 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
    • 31 Jan 2017 Results assessing association of clinical events with Everolimus exposure with low doses of Tacrolimus (n=309) published in the American Journal of Transplantation
    • 01 Mar 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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