A Phase 3 Trial Testing Immunosuppression Changes With or Without IVIG to Treat BK Polyomavirus Infection in Kidney and Kidney-Pancreas Transplant Patients

What this Trial Is About

This trial investigates polyomavirus infections BKPyV in people who have received kidney or simultaneous pancreas-kidney transplants. The study aims to evaluate how reducing or modifying immunosuppression, with or without intravenous immunoglobulin IVIG, affects BKPyV infection, transplant function, graft loss, acute rejection, immunosuppression levels, and survival. BKPyV infection is a serious complication due to the immune system suppression needed after transplantation, which can increase infection risks and damage the transplant. Participants will be randomly assigned to one of two groups one receiving immunosuppression reduction or modification plus IVIG, and the other receiving immunosuppression reduction or modification alone as part of standard care. The immunosuppression adjustments may include dose reductions or switches to less potent medications. IVIG is an antibody treatment with potential antiviral and immune-modulating effects, used here as an additional therapy for BKPyV infection. During the study, participants will be monitored for up to 48 weeks with assessments including viral load, kidney function eGFR, transplant rejection, antibody presence, infection events, hospitalizations, quality of life, cancer diagnosis, and adverse events. The main outcome measured at 11 to 13 weeks combines death, graft loss, kidney function decline, rejection, viral load, and immunosuppression load. Safety and treatment effects will be closely followed throughout the study period.

A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients