PHASE III MULTI-CENTER OPEN LABEL RANDOMIZED CLINICAL TRIAL COMPARING EVEROLIMUS AND LOW DOSE TACROLIMUS TO TACROLIMUS AND MYCOPHENOLATE MOFETIL AT 6 MONTHS POST HEART TRANSPLANT TO PREVENT LONG-TERM COMPLICATIONS AFTER PEDIATRIC HEART TRANSPLANTATION
What is the goal of the study?
This is a multi-center, open label, randomized clinical trial, that will enroll approximately 210 subjects overall and last about 5 years. The aim is to test the hypothesis that among children who survive to 6 months post-heart transplantation (HT), those randomized to Everolimus and low-dose Tacrolimus (EVL/LDTAC) for 30 months will have a lower total burden of three major adverse transplant events: cardiac allograft vasculopathy (CAV), chronic kidney disease (CKD), and biopsy-proven acute cellular rejection (BP-ACR), as defined by the MATE-3 score, compared to children randomized to standard therapy with Tacrolimus and Mycophenolate Mofetil (TAC/MMF). Additional aim is to determine the tolerability of EVL/LDTAC compared to TAC/MMF for prevention of major post-transplant complications by characterizing the frequency and incidence of AEs that are at least possibly related to Everolimus and low-dose Tacrolimus or TAC/MMF.
Who can participate in the study?
Please contact the study team listed below to learn more.