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
- Conditions
- kidney transplantion -Epstein Barr virusTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2024-515075-36-00
- Lead Sponsor
- es Hopitaux Universitaires De Strasbourg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method