A phase IV open label randomised controlled trial of rituximab in induction therapy for living donor renal transplantation

Guy's and St Thomas' Hospital NHS Foundation Trust (UK)0 个研究点目标入组 316 人开始时间: 2009年12月15日最近更新: 2023年2月6日

适应症

试验速览

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•1. Adult patients aged over 18 years, either sex
•2. Receiving their first living donor renal transplant, or their second if the first was not lost from acute rejection
•3. Have given written informed consent

•Amendments as of 22/12/2010:
•Point 8 of the below exclusion criteria has been amended to read as follows:
•8. Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 90 days prior to transplant
•Initial information at time of registration:
•1. Previous other organ transplants lost through acute rejection
•2. Patients undergoing antibody removal
•3. Patients with other organ transplants
•4. Patients previously treated with cylophosphamide, ATG, OKT3 or rituximab
•5. Patients with white cell count below 4,500/mm^3
•6. Patients with platelet count below 1,500/mm^3
•7. Patients who are treated with drugs that are strong inhibitors or inducers of cytochrome P450, or treated with terfenadine, astemizole, cisapride or lovastatin
•8. Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 30 days prior to transplant
•9. Pregnant or breastfeeding women
•10. 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
•11. Patients known to be human immunodeficiency virus (HIV), hepatitis B or C surface antigen positive
•12. Patients who in the opinion of the Investigator would not be a suitable candidate for study participation

发起方

Guy's and St Thomas' Hospital NHS Foundation Trust (UK)