Multicenter Randomized Trial of Everolimus in Pediatric Heart Transplantation
Abstract
TEAMMATE is a multicenter randomized clinical trial of a novel immunosuppressive therapy that is studying 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. 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, enrollment is complete and the target has been met, with 211 patients randomized and 170 have completed the trial (30 months follow-up). Additional accomplishments in Year 05 include the launch of a Trial Biobank and biospecimen collection (32 plasma samples to date); successful execution of two Data and Safety Monitoring Board meetings; submission of the Trial Design paper; a Continuing Medical Education feature on TEAMMATE (#PHTS Live); and the continuation of endpoint adjudication.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2022
- Accession Number
- AD1200103
Entities
People
- Lynn A Sleeper