Tacrolimus Everolimus Against Tacrolimus Mycophenolate mofetil in Pediatric Heart Transplant Recipients using the Major Adverse Transplant Events Score
Study ID: STU 122017-025
This is a Phase 3 multi-center open label randomized clinical trial. The primary aim of the study is to test the hypothesis that, among children who survive to 6 months post-HT, children randomized to eVL/LDTaC will have a lower total burden of three major adverse transplant events -CaV, CKD and BP-aCR as defined by MaTe-3-compared to children randomized to TaC/MMF, without a higher predicted risk of death/graft loss due to all causes as defined by MaTe-6. The rationale for this approach is that while we wish to focus on reducing the three transplant complications that eVL has been shown to affect, we would not want to omit from consideration death/graft loss events caused by other major adverse transplant events, such as infection, as was found in an adult heart transplant trial of eVL and cyclosporine (reference population cyclosporine/MMF).2 Thus MaTe-3 is the primary efficacy endpoint whereas MaTe-6, which is predictive of all-cause graft loss, is the primary safety endpoint. a schematic diagram of the trial can be found in Section 6 of the protocol (Figure 6-1). Patients will be randomized at 6 months post-HT if they meet the study eligibility criteria and provide informed consent. Subjects will be followed for a total of 30 months post-randomization.