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临床试验/NCT00239031
NCT00239031已完成3 期

Multicentre, Controlled, Prospective, Randomized, Open-label Clinical Trial to Compare Enteric-Coated Mycophenolate Sodium (EC-MPS) Plus Reduced Dose Cyclosporine Microemulsion (CsA-ME) Vs EC-MPS Plus Standard Dose CsA-ME in Elderly de Novo Renal Transplant Recipients Treated With Basiliximab and Short-term Steroids

Novartis0 个研究点目标入组 117 人开始时间: 2002年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Novartis
入组人数
117
主要终点
The 6-month study values of creatinine clearance, as calculated according to Cockcroft and Gault, summarized and compared between treatment groups.

研究概览

简要总结

All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.

The aim of this study is to compare the renal function, 6 months after transplant, in de novo old-age renal transplant recipients treated with EC-MPS plus reduced dose CsA-ME or with EC-MPS plus standard dose CsA-ME, both in combination with basiliximab and short-term oral steroids.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

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

结局指标

主要结局

The 6-month study values of creatinine clearance, as calculated according to Cockcroft and Gault, summarized and compared between treatment groups.

次要结局

  • Incidence of treatment failure (biopsy-proven and/or treated acute rejection, graft loss, death or loss to follow-up at 6 and 12 months;
  • Incidence of biopsy proven acute rejection at Month 6 and 12
  • Incidence of graft loss at Month 6 and 12
  • Rate of delayed graft function (DGF) and the time to adequate renal function (serum creatinine < 2,5 mg/dL);
  • Pharmacokinetics of MPA and MPAG at Day 15, Month 3 and Month 6

研究者

发起方
Novartis
申办方类型
Industry

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