临床试验/NCT00238953

NCT00238953已完成4 期

A Prospective, Open Label Protocol to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Novartis1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2005年2月最近更新: 2017年2月23日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Novartis
入组人数: 30
试验地点: 1
主要终点: patient and graft survival

研究概览研究设计入排标准研究组 & 干预措施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

Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.

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: Prevention
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

未提供

排除标准

未提供

研究组 & 干预措施

EC MPS

Experimental

干预措施: Enteric-Coated Mycophenolate Sodium (EC-MPS) (Drug)

结局指标

主要结局

patient and graft survival

graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate),

6 Month evaluation

acute rejection (suspected or biopsy confirmed)

infections, adverse events, serious adverse events.

次要结局

Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation

研究者

发起方

Novartis

申办方类型

Industry

研究点 (1)

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