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临床试验/EUCTR2009-017066-23-GB
EUCTR2009-017066-23-GB进行中(未招募)不适用

A randomized trial of Rituximab in induction therapy for living donor renal transplantation - Randomized trial of rituximab in renal transplantation

Guys and St Thomas Foundation Trust0 个研究点开始时间: 2010年3月17日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • Adult patients over 18 years receiving their first living donor renal transplant, or their second if the first was not lost from acute rejection.
  • Patients who have given written informed consent.
  • If female and of child bearing potential, taking adequate contraception.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 0
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Previous other organ transplants lost through acute rejection
  • Patients undergoing antibody removal.
  • Patients with other organ transplants.
  • Patients previously treated with cylophosphamide, ATG, OKT3 or rituximab.
  • Patients with white cell count below 3.6x10^9/L; Inclusion of patients with white blood cell counts less than 4.0x10^9/L, but higher than 3.6x10^9/L will be left to the discretion of the Principal Investigator.
  • Patients with platelet count below 100x10^9/L
  • Patients who are treated with drugs that are known to have clinically significant interactions with tacrolimus and those treated with with terfenadine, astemizole, cisapride or lovastatin.
  • Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 90 days prior to transplant.
  • Pregnant or breastfeeding women
  • Patients with a documented history of malignancy and its origins and treatment in the last five years. Localised basal cell carcinoma of the skin is permitted
  • Patients known to be HIV, Hepatitis B surface antigen or Hepatitis C antibody positive.
  • Prisoners or young offenders.
  • Patients who in the opinion of the Investigator would not be a suitable candidate for study participation.
  • Women of child bearing potential not willing to take adequate contraception.

研究者

发起方
Guys and St Thomas Foundation Trust

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A randomized trial of Rituximab in induction therapy... | 临床试验