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

Novartis0 个研究点目标入组 48 人开始时间: 2002年5月1日最近更新: 2010年8月25日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novartis
入组人数: 48
主要终点: Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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)

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•First cadaveric liver transplant
•ABO identical or compatible graft

排除标准

•Multiple organ transplant
•renal impairment defined as glomerular filtration rate (GFR) < 30 ml/min
•Fulminant liver failure
•Other protocol-defined exclusion criteria may apply.

结局指标

主要结局

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

次要结局

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.

研究者

发起方

Novartis

申办方类型

Industry

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