An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of the study are:To compare the renal function of a quadruple immunosuppressive regimen (including basiliximab in combination with an optimized cyclosporine dose during the first weeks post-transplantation, mycophenolate mofetil and corticosteroids) versus a standard triple therapy regimen (including cyclosporine standard dose, mycophenolate mofetil and corticosteroids)

• Phase: Phase 4

Details

• Lead Sponsor: Novartis
• Treatments: Antibodies, Monoclonal; Basiliximab; Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria

• First cadaveric liver transplant

• ABO identical or compatible graft

Exclusion Criteria

• Multiple organ transplant

• renal impairment defined as glomerular filtration rate (GFR) < 30 ml/min

• Fulminant liver failure

Other protocol-defined exclusion criteria may apply.