Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients

Novartis Pharmaceuticals4 个研究点分布在 2 个国家目标入组 45 人开始时间: 2000年6月最近更新: 2017年2月23日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 45
试验地点: 4
主要终点: Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data.

研究设计

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

入排标准

年龄范围: 1 Week 至 16 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Male and female patients no more than 16 years of age.
•Patients receiving a primary cadaveric or non-HLA identical living donor (related or unrelated) renal transplant.
•The graft must be functional within 48 hours post transplantation.

排除标准

•Cold ischemia time greater than 40 hours.
•Patients who are recipients of multiple solid organ transplants, including dual and en bloc kidneys, or who have previously received transplanted organs.
•Patients with panel reactive T cell antibodies of 50 % or higher at the last assessment before transplantation.

结局指标

主要结局

Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections.

次要结局

Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up.

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

研究点 (4)

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