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

Novartis

Status and phase: Completed; Phase 4

Conditions: Liver Transplantation

Treatments: Drug: Basiliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00343226

CCHI621ABE02

Details and patient eligibility

About

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)

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)