Pediatric Heart Transplant Immunosuppressive Therapy Comparing Two Regimens: The TEAMMATE Study – Phase III

Clinical Trial Comparing Everolimus and Low-Dose Tacrolimus to Tacrolimus and Mycophenalate Mofetil at 6 Months Post Heart Transplant to Prevent Long-Term Complications after Pediatric Heart Transplantation

Protocol Description

The purpose of this multi-center study is to learn more about which anti-rejection medications best protect infants, children, adolescents, and young adults after they have had a heart transplant. Researchers hope to learn which medications are best at preventing rejection, and also which medications are best at preventing long-term problems after heart transplant, including kidney disease, infection, coronary artery disease, and post-transplant lymphoproliferative disease. Researchers will be comparing effectiveness of the current standard of care for pediatric heart transplant immunosuppression, a combination of the drugs tacrolimus (TAC) and mycophenalate mofetil (MMF), to another regimen using low-dose tacrolimus (LDTAC) and everolimus (EVL).

Study Level: Phase III

Eligibility Criteria

The study is enrolling people who were younger than 21 at the time of their heart transplant, providing that they show no sign of rejection at their 6-month post-surgery evaluation.
Males and Females: Patients who had a heart transplant at an age less than 21


Following screening participants will be randomly segmented into groups that will either take TAC plus MMF or LDTAC plus EVL. Participants will be seen by the study team for testing and evaluations every 3 months for 4 visits and again every 6 months thereafter for the final 3 visits.
Visits: 8 including screening
Duration: 30 months

Status: Enrolls from Current Patient Cases

Source(s) of Support

U.S. Department of Defense
Stanford University
Boston Children’s Hospital

Primary Investigator

Brian Feingold, MD

Contact Information

For more information about the study, please contact:
Maggie Abraham, CCRC