Multicenter randomized two arms study evaluating the efficacy of prophylactic Rituximab in adult EBV negative kidney transplant recipients on incidence of EBV primary infection and post-transplant lymphoproliferative disorders - REPLY

es Hôpitaux Universitaires de Strasbourg0 个研究点目标入组 120 人开始时间: 2021年4月21日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•-Adult patients (age =18 years at transplantation)
•-Kidney and kidney pancreas simultaneous transplantation
•-EBV seronegative patients (IgG anti EBNA, IgG anti VCA and IgM anti VCA negative) (from 6 months before transplantation to the day of transplantation, included)
•-Patient who have given written informed consent
•-Negative pregnancy test and use of contraception during all the study
•-EBV positive donor
•-Patient affiliated to a social security scheme
•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 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•-Patient with known HBV active infection
•-Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients
•-Active severe infection
•-Severe Immune deficiency
•-Severe cardiac insufficiency
•-Pregnant or lactating women
•-Women of child bearing potential unless they are using an acceptable birth control methods
•-Patient under judicial protection or under guardianship
•-Patient currently participating in another clinical trial investigating drugs. Observational studies are not considered as an exclusion criterion
•-Any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, is incompatible with the participation in the study
•-Unlikely to comply with the visits scheduled in the protocol

发起方

es Hôpitaux Universitaires de Strasbourg