Digestive System Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Liver Diseases

Liver Cirrhosis

Liver Neoplasms

Hepatic Insufficiency

Liver Failure

Gastrointestinal Diseases

Fibrosis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Anti-Infective Agents

Everolimus

Tacrolimus

Liver Extracts

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Standard immunosuppression protocol with Tacrolimus, maintaining trough levels between 6 and 12 ng/ml in the first month, in association with steroids (20 mg/day with subsequent weaning within 3 months after transplantation).

Administration of Everolimus in association with Tacrolimus and steroids.

Administration of Everolimus within 24 hours from the time of randomization (7 days from the time of transplantation) in association with Tacrolimus and steroids. The first dose level of the trough will be performed at day 7 after initiation of therapy. After the reaching an Everolimus trough level of \>5ng/ml (final target 6-12 ng/ml), there will be a gradual weaning of tacrolimus (bringing Tacrolimus blood levels \<5 ng/ml) with discontinuation of Tacrolimus within 30 days after transplantation when possible.

Umberto Cillo, MD

Laura Saracino, MSc

Michele Colledan, MD

Vittorio Corno, MD

Giorgio Rossi, MD

Paolo Reggiani, MD

Luciano De Carlis, MD

Jacopo Mangoni, MD

Laura Saracino, MBS

Giacomo Zanus, MD

Daniele Neri, MD

Patrizia Boccagni, MD

Francesco D'Amico, MD

Enrico Gringeri, MD

Alessandro Vitale, MD

Pasquale Bonsignore, MD

Paolo Feltracco, MD

Dino Sgarabotto, MD

Roberto Marchini, MD

Angelica Magrofuoco, CCTC

Salvatore Agnes, MD

Erida Nure, MD

Mauro Salizzoni, MD

Francesco Lupo, MD

Fabio Bresàdola, MD

Umberto Baccarani, MD

Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.

This prospective study was designed to evaluate the feasibility and effectiveness of the use of Everolimus in the minimization and possible suspension of calcineurin inhibitors in adult liver transplant patients. The study will take into account a control group (standard immunosuppression with tacrolimus and steroids) after induction with anti-IL2 Antibodies.

Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study

Terapia Con Everolimus Nel Trapianto de Novo di Fegato: Uno Studio Multicentrico Randomizzato

Patients not requiring calcineurin inhibitors (CNI)

Impact of therapy on renal function, evaluated by creatinine clearance according to the Modification of Diet in Renal Disease (MDRD) Study.

Evaluation of common post Liver Transplantation Adverse Events:

wound healing, bone marrow depression, hyperlipidemia, proteinuria, diabetes mellitus, diagnosed hypertension, infections, levels of HCV.

Azienda Ospedaliera di Padova

Director of the Hepatobiliary Surgery and Liver Transplantation Unit

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study	NCT01423708	Liver Failure Liver Diseases Liver Cirrhosis Liver Neoplasms	Everolimus	18 Years - 70 Years	Azienda Ospedaliera di Padova
Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study	NCT01423708	Liver Failure Liver Diseases Liver Cirrhosis Liver Neoplasms	Everolimus	18 Years - 70 Years	Azienda Ospedaliera di Padova
Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study	NCT01423708	Liver Failure Liver Diseases Liver Cirrhosis Liver Neoplasms	Everolimus	18 Years - 70 Years	Azienda Ospedaliera di Padova

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