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临床试验/EUCTR2013-004538-14-IT
EUCTR2013-004538-14-IT
进行中(未招募)
不适用

Identification of a specific systemic transcriptome able to differentiate patients with renal transplantation in chronic treatment with tacrolimus from those with mTOR inhibitors. - NA

Azienda Ospedaliera Universitaria Integrata Verona0 个研究点目标入组 40 人2014年2月19日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Renal Transplantation
发起方
Azienda Ospedaliera Universitaria Integrata Verona
入组人数
40
状态
进行中(未招募)
最后更新
11年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2014年2月19日
结束日期
待定
最后更新
11年前
研究类型
Interventional clinical trial of medicinal product
性别
All

研究者

入排标准

入选标准

  • Written informed consent
  • age \> 18 years
  • first renal transplantation
  • renal transplantation performed since more than 6 months at the time of enrollment
  • estimated GFR (as assessed by the use of the equation aMDRD) greater than 30 mL / min
  • Chronic treatment with tacrolimus or mTOR inhibitors (everolimus, sirolimus) in
  • combination with mycophenolate mofetil (MMF) since more than 6 months
  • Blood levels between 4\-8 ng/ml (Tacrolimus) and 4\-8 ug/L (inhibitors
  • Chronic treatment with corticosteroid (prednisone 5 mg or 4 mg of methylprednisolone)
  • Are the trial subjects under 18? no

排除标准

  • Patients participating in another study
  • Change in GFR\> 30% in the 6 months prior to enrollment
  • Diagnosis and treatment of acute rejection in the 6 months prior to enrollment
  • other solid organ transplantation in combination with renal transplantation
  • Malignant neoplasm in the active phase (excluding non\-melanoma skin cancer)
  • Hemodialysis
  • Severe acute and chronic liver disease (hepatitis B virus\-related, hepatitis C virus\-related, toxic,
  • immunoallergic)
  • Women with a positive pregnancy test at enrollment
  • Pregnant or breastfeeding women or women not using effective contraception if

结局指标

主要结局

未指定

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