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A Multi-center, Randomized, Open-label, Parallel Group Study Investigating the Renal Tolerability, Efficacy and Safety of a CNI-free Regimen (Everolimus and MPA) Versus a CNI-regimen With Everolimus in Heart Transplant Recipients

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Trial Profile

A Multi-center, Randomized, Open-label, Parallel Group Study Investigating the Renal Tolerability, Efficacy and Safety of a CNI-free Regimen (Everolimus and MPA) Versus a CNI-regimen With Everolimus in Heart Transplant Recipients

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 09 Nov 2021

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At a glance

  • Drugs Everolimus (Primary) ; Mycophenolic acid (Primary) ; Ciclosporin; Corticosteroids; Mycophenolate mofetil; Mycophenolate sodium; Tacrolimus
  • Indications Heart transplant rejection
  • Focus Pharmacodynamics
  • Acronyms MANDELA
  • Sponsors Novartis; Novartis Pharmaceuticals

Most Recent Events

  • 18 Mar 2019 Primary endpoint (Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18) has been met, according to the results published in the American Journal of Transplantation.
  • 18 Mar 2019 Results comparing everolimus-based immunosuppression with reduction or withdrawal of calcineurin inhibitor reduction from six months after heart transplantation, published in the American Journal of Transplantation
  • 06 Jun 2018 Results presented at the 2018 American Transplant Congress

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