Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy

Presentation of Renal Function in Liver Transplant Recipients With Certican Therapy: PROTECT Study A Twelve-month, Multicenter, Randomized, Open-label Study of Safety, Tolerability and Efficacy of Certican-based Regimen Versus Calcineurin Inhibitor-based Regimen in de Novo Liver Transplant Recipients

The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.

Inclusion Criteria:

• Males or females 18 - 70 years old
• Liver transplant recipient (living or deceased donor)
• Patients in whom an allograft biopsy will not be contraindicated

Exclusion Criteria:

• Recipients of multiple solid organ transplants or patients that have already received a transplant in the past
• HCV positive patients who need an active anti-viral treatment (HCV- positive patients without active antiviral treatment are allowed)
• HIV positive patients
• Patients who are breast feeding
• Patients with a current severe systemic infection
• Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)
• Preexisting (i.e. not related to CNI-damage) renal dysfunction that, according to the judgment of the investigator, will not significantly improve after transplantation (i.e., for example, patients that are expected to have a cGFR below 50ml/min at 4 weeks post transplantation)
• Patients that have received Simulect prior to this study.
• Other protocol-defined inclusion/exclusion criteria may apply.