Evaluation of the Efficacy of a Treatment by One Single Dose of Rituximab (375mg/m2 ) in the Prevention of the Epstein Barr Virus (EBV) Primary Infection and Post-transplant Lymphoproliferative Disorder in Adult EBV Seronegative Patients Who Received an EBV Seropositive Kidney Allograft (REPLY)
Epstein-Barr Virus Infections
About this trial
This is an interventional prevention trial for Epstein-Barr Virus Infections
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion criteria:
- Patient with known HBV active infection
- Allergy to Rituximab
- Severe Immune deficiency
- Severe cardiac insufficiency
- Pregnant or lactating women
- Women of child bearing potential unless they are using a birth control method
- 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.
Exclusion Criteria:
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Sites / Locations
- Les Hôpitaux Universitaires de StrasbourgRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental group
control group
Prophylactic treatment with Rituximab: one single dose of 375mg/m2 intravenous 7 days before transplantation in case of living donor or at time of transplantation (D0 or D1) in case of transplantation with a deceased donor.
Immunosuppression treatment will be given according to the practice of the centers; use of Thymoglobuline is strongly discouraged because of EBV seronegativity and risk of lymphoma. Basiliximab is recommended for induction therapy. Recommended maintenance immunosuppression consists in a calcineurin inhibitor (tacrolimus or ciclosporine), MMF and Steroids