A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The aims of the study was to evaluate the safety and efficacy of early introduction one month post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de novo liver transplant recipients and to evaluate if it leads to a better renal function 6 month post-transplantation compared to standard treatment associating tacrolimus and EC-MPS.

The renal function was estimated by glomerular filtration rate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Basiliximab; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Key Inclusion Criteria:

• Man or woman aged 18 years or greater, recipient of a primary liver transplant from a deceased donor with whole or split liver

Key Exclusion Criteria:

• Patient recipient of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant

• Recipient of a liver from a living donor or cadaveric non heart beating donor

• ABO incompatible transplant graft

• Transplantation following autoimmune liver hepatitis, primitive sclerosing cholangitis or primitive biliary cirrhosis

• Estimated glomerular filtration rate ≤ 30ml/min at selection

• History of malignancy within the 5 past years, other than non-metastatic basal or squamous cell carcinoma and hepatocellular carcinoma

• Alpha-foeto-protein > 1000 ng/ml (only in case of hepatocellular carcinoma)