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 26 centers, with leadership at Boston Children's Hospital (Data Coordinating Center) and Stanford University (Clinical Coordinating Center). At the time of this annual report, 25 of 26 centers are fully initiated and able to screen and enroll patients. A total of 151 patients have been randomized (108 in the last year). Additional accomplishments in Year 02 include one in-person Protocol Certification Trainings; the addition of two study sites; successful execution of two Data and Safety Monitoring Board meetings and an in-person Steering Committee meeting; acceptance of a research abstract on everolimus dosing; and creation of a Spanish language informed consent video for families, and the commencement of regulatory/data audit site visits.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2019
- Accession Number
- AD1086145
Entities
People
- Lynn A Sleeper