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临床试验/EUCTR2007-000771-42-SE
EUCTR2007-000771-42-SE进行中(未招募)不适用

A controlled randomized open-label multicentre study evaluatiing if early conversion to everolimus (Certican) from cyclosporine (Neoral) in de novo renal transplant receipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy - CENTRA

ovartis Pharma Services0 个研究点目标入组 250 人开始时间: 2007年8月22日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
250

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Male or female above 18 year
  • first or second renal transplant receipients
  • willing and capable of giving written informed consent
  • at randomisation:
  • maintained on a triple immunosuppresive regime
  • completed period 1 without experiencing biopsy proven acute rejection
  • negative pregnancy test and on medically approved birth control metod
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • recipients of multi organ transplants
  • receiving renal transplant from HLA-identical sibling
  • past or present malignancy
  • receipients of ABO incompatible transplants
  • at randomisation:
  • hemoglobin count <80g/l and/or platelet count <50x109/l and/or white blood cell count < 2.5 x 109/l)
  • spot urinary protein/creatinine ratio >150 mg/mmol
  • requiring dialysis and/or having a cGFR <20ml/min

研究者

发起方
ovartis Pharma Services

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