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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

RecruitingPhase 4Ages 18 Years - anyAllUniversity Hospital, Strasbourg, France
NCT04989491 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Epstein Barr virus infects over 90% of human population and persists during lifetime. After infecting B lymphocytes, EBV remains latent in memory B cells. In immunocompromised patients, primary infection could lead to an uncontrolled EBV infected B cells proliferation because of impaired T cell specific cytotoxicity. The latent EBV infection is characterized by expression of restricted latent gene products, which drive cell proliferation and progression to PTLD. As a consequence, EBV seronegativity and EBV mismatch are major risk factors for developing PTLD. The investigators reported in a previous work from the French Registry that the incidence of PTLD was multiplied by ten in adult EBV negative kidney transplant recipients. Moreover, even if the event is relatively rare after transplantation, the prognosis is severe with high morbidity and an overall mortality rate around 50%. Nowada

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📋 Eligibility rules (as published)
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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What it tests

  • Rituximab
  • control group
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Where

1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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