A National, Multi-center, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Everolimus Combined With Enteric-coated Mycophenolate Sodium Compared to the Standard Treatment Combining Tacrolimus and Enteric-coated Mycophenolate Sodium in de Novo Liver Transplant Recipients
Phase of Trial: Phase III
Latest Information Update: 29 Apr 2016
At a glance
- Drugs Everolimus (Primary) ; Basiliximab; Mycophenolate sodium; Tacrolimus
- Indications Liver transplant rejection
- Focus Pharmacodynamics; Registrational
- Acronyms SIMCER
- Sponsors Novartis Pharmaceuticals
- 25 Mar 2016 Time frame for primary endpoint changed from 'randomization to month 6 post-transplantation' to 'baseline, week 24'.
- 01 Dec 2015 Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov record.
- 13 Sep 2015 Trial design presented at the 17th Congress of the European Society for Organ Transplantation.