Prevention of Cardiac Allograft Vasculopathy Using Rituximab (Rituxan) Therapy in Cardiac Transplantation (CTOT-11)

This is a phase 2, prospective, multi-center, randomized, placebo-controlled clinical trial in which 300 primary heart transplant recipients with a negative PRA will be randomized (1:1) to placebo (IV day 0 and 12 post-transplant) plus conventional immunosuppression (tacrolimus or equivalent, MMF or equivalent, and rapid steroid taper) versus induction therapy with anti-CD20 mAb (1gm IV on day 0 and day 12 post-transplant) plus conventional immunosuppression.