EUCTR2020-000492-21-FRActive, not recruitingPhase 1
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 sites120 target enrollmentStarted: April 21, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
- •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
Exclusion Criteria
- •-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
Investigators
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