Study of Single-Dose Rituximab to Prevent Epstein-Barr Virus Infection and Lymphoproliferative Disorder in Adults Receiving EBV Positive Kidney Transplants

What this Trial Is About

Epstein-Barr virus EBV infects over 90% of people and stays in the body for life, usually in memory B cells. In adults who receive kidney transplants from EBV positive donors but are themselves EBV negative, there is a high risk of developing post-transplant lymphoproliferative disorder PTLD, a serious condition with high mortality. This study aims to evaluate if an early single dose of Rituximab can prevent EBV infection and PTLD in this high-risk group. Participants will be divided into two groups one receiving a single intravenous dose of Rituximab 375 mgm2 either 7 days before transplant for living donors or on the day of transplant for deceased donors, and a control group receiving no treatment. All participants will receive standard immunosuppressive therapy, excluding Thymoglobuline and favoring Basiliximab for induction, along with maintenance therapy of a calcineurin inhibitor, MMF, and steroids. During the study, participants will be monitored for EBV infection for one year after transplantation. Researchers will assess the occurrence of primary EBV infection as the main outcome. Patients will undergo regular evaluations including blood tests to detect EBV status and other clinical assessments. The study follows participants over the course of one year to track infection and any development of PTLD, ensuring safety and adherence to the treatment protocol.

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