Multicenter randomized two arms study evaluating the efficacy of prophylactic Rituximab in EBV negative kidney transplant recipients on incidence of EBV primary infection and post-transplant lymphoproliferative disorders -REPLY - 7678

es Hopitaux Universitaires De Strasbourg0 个研究点目标入组 100 人开始时间: 2024年6月20日最近更新: 2024年7月22日

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), Pediatric patients > 2 years and <18 years at transplantation, Patient who have given written informed consent, Negative pregnancy test and use of contraception during all the study or during 12 months after the administration of rituximab in case of early discontinuation of study-EBV positive donor, EBV positif donnor

•Patient with known HBV active infection, Unlikely to comply with the visits scheduled in the protocol, Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients, Active severe infection, Severe Immune deficiency, 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

发起方

es Hopitaux Universitaires De Strasbourg