Multi-Center, Open-Label, Prospective, Randomized, Parallel Group, Long-Term Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a CNI [Calcineurin-inhibitors] -Free Regimen and a CNI-Low Dose Regimen

Trial Profile

Multi-Center, Open-Label, Prospective, Randomized, Parallel Group, Long-Term Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a CNI [Calcineurin-inhibitors] -Free Regimen and a CNI-Low Dose Regimen

Completed
Phase of Trial: Phase III

Latest Information Update: 02 May 2018

At a glance

  • Drugs Everolimus (Primary) ; Basiliximab; Ciclosporin; Mycophenolate mofetil; Mycophenolate sodium; Mycophenolic acid; Sirolimus
  • Indications Renal transplant rejection
  • Focus Therapeutic Use
  • Acronyms HERAKLES
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 02 May 2018 Results (n=417) of five-year outcomes in kidney transplant patients randomized to everolimus with cyclosporine withdrawal or low-exposure cyclosporine versus standard therapy, were published in the American Journal of Transplantation.
    • 23 Aug 2016 5 year follow up results presented at the 26th International Congress of the Transplantation Society.
    • 16 Sep 2015 Results of 48 months follow up presented at the 17th Congress of the European Society for Organ Transplantation
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