Multicenter Randomized Trial of Everolimus in Pediatric Heart Transplantation
Abstract
TEAMMATE is a multicenter randomized clinical trial of a novel immunosuppressive therapy that will study 210 children who have undergone recent heart transplantation. The primary goal is to determine whether a new rejection treatment (everolimus and low-dose tacrolimus) can reduce or prevent complications of transplant, including rejection, coronary artery disease, and kidney disease, when compared to usual care (tacrolimus and mycophenolate mofetil). The secondary goal is to acquire FDA approval of the first immunosuppression regimen for pediatric heart transplantation. The primary trial endpoint is a validated surrogate measure the major adverse transplant event (MATE) score which efficiently predicts long-term survival, and that has been accepted by the FDA (IND# 127980). The trial is being conducted at 25 centers, with leadership at Boston Children's Hospital (Data Coordinating Center) and Stanford University (Clinical Coordinating Center). At the time of this annual report, 21 of 25 centers are fully initiated and able to screen and enroll patients. A total of 43 patients have been randomized. Additional accomplishments in Year 01 include two in-person Protocol Certification Trainings; implementation of a single/central Institutional Review Board; successful execution of two Data and Safety Monitoring Board meetings and a Steering Committee meeting; development of MATE Adjudication Guidelines; and creation of an informed consent video for families, the Data Management system and the portal for upload of coronary angiograms to the Angiographic Core Laboratory.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2018
- Accession Number
- AD1063803
Entities
People
- Lynn A Sleeper