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

Novartis48 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Transplantation

Interventions

BasiliximabDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation

Secondary Outcomes

Frequency and severity of rejection episodes before 6 and 12 months post-transplantation

Frequency of death, graft loss or retransplantation before 6 and 12 months post-transplantation

Adverse events

Duration of initial hospitalization and number or hospital re-admissions.

Data from ClinicalTrials.gov

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