Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients

Novartis Pharmaceuticals171 enrolled

Overview

The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In addition this study will assess the safety and tolerability of a cyclosporine A regimen based on C-2h monitoring in comparison to the standard tacrolimus regimen.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

171

Conditions

Liver Transplant

Interventions

Cyclosporine ADRUG

TacrolimusDRUG

BasiliximabDRUG

Each patient was given two 20mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery.

Methylprednisolone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * About to undergo a primary liver transplant (including living donor, non-heart beating donor and split liver). * Age between 18 and 75 years. * Expected to be able to receive the first oral dose of CNI within the first 24 hours post-transplantation (Tx) Exclusion Criteria: * This is a multi-organ transplant or if the patient has previously been transplanted with any other organ. * Urine production is \<200 ml within 12 hours after reperfusion of the graft * Severe coexisting disease is present or if any unstable medical condition is present which could affect the study objectives. Other protocol-defined exclusion criteria applied

Locations (1)

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation.

A BPAR is defined when the investigator had a suspicion of an acute rejection, where the final clinical diagnosis confirmed the occurrence of an acute rejection, where a biopsy was performed that confirmed the presence of an acute rejection, and where anti-rejection treatment intervention was initiated. The efficacy measured the first rejections (clinically and biopsy proven rejections) at 3 months.

Time frame: Month 3

Data from ClinicalTrials.gov

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