A 15-Month, Multi-Center, Randomized, Open-Label, Parallel Group Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-Free Regimen (Everolimus and Mycophenolic Acid) Versus a Standard Regimen (Cyclosporine A and Everolimus) in de Novo Heart Transplant Recipients.

Trial Profile

A 15-Month, Multi-Center, Randomized, Open-Label, Parallel Group Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-Free Regimen (Everolimus and Mycophenolic Acid) Versus a Standard Regimen (Cyclosporine A and Everolimus) in de Novo Heart Transplant Recipients.

Completed
Phase of Trial: Phase IV

Latest Information Update: 11 Sep 2017

At a glance

  • Drugs Everolimus (Primary) ; Mycophenolic acid (Primary) ; Ciclosporin
  • Indications Heart transplant rejection
  • Focus Therapeutic Use
  • Acronyms MANDELA
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 14 Apr 2017 Status changed from active, no longer recruiting to completed.
    • 02 Aug 2016 Planned End Date changed from 1 Jul 2017 to 1 Apr 2017.
    • 02 Aug 2016 Planned primary completion date changed from 1 Jul 2017 to 1 Apr 2017.
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