Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant
PRIVENT_FSGS
What is the goal of the study?
This is a phase III, multicenter, randomized, open label, clinical trial to test that hypothesis that plasmapheresis plus rituximab prior to kidney transplantation can prevent recurrent FSGS in children and adults. Primary Objective: • To determine the difference in rate of recurrent FSGS after 1 year post-transplant in patients receiving plasmapheresis and rituximab prior to kidney transplantation compared to those receiving plasmapheresis alone. Secondary Objectives: • To determine the safety and tolerability of plasmapheresis and rituximab prior to kidney transplant • To determine the effect of preemptive plasmapheresis and rituximab on graft and patient survival at 1 year post-transplant • To determine the effect of preemptive plasmapheresis on graft function and frequency of acute rejection at 1 year post-transplant • To determine the time to reconstitution of CD19+ B-cells after treatment with pre-emptive rituximab • To determine the effect of preemptive plasmapheresis and rituximab to delay the onset of recurrent FSGS post-transplant Primary Endpoint: • Recurrent FSGS at 1 year post-transplant Secondary Endpoints: • Recurrent FSGS free survival • Graft survival at 1 year post-transplant • Patient survival at 1 year post-transplant • Graft function at 1 year post-transplant (eGFR by bedside Schwartz equation for age ≤17 years and CKD-EPI for age ≥18 years) • Proportion with acute rejection at 1 year post-transplant • Proportion with CD19+ <1% at 1 month, 6 months, and 12 months>
Who can participate in the study?
Please contact the study team listed below to learn more.