Study Design & Medications
TEAMMATE is a randomized trial, with all participants receiving some form of anti-rejection medication. Children participating in the TEAMMATE trial have a 50:50 chance to be randomized to either:
- 1. Tacrolimus and Mycophenolate
- 2. Everolimus* and Tacrolimus
- *For a helpful brief video on "How to Prepare Liquid Everolimus" please visit this link: How to Prepare Liquid Everolimus
Randomization works like the flip of a coin. Children in the study cannot choose which combination of medicines they want to take. Once randomized, children will stay in the trial for 30 months.
Your Transplant Cardiologist can answer questions about the TEAMMATE trial and about the trial medicines. Children and parents participating in this trial will be provided with detailed information about their anti-rejection regimen.
A Transplant Cardiologist will determine which children are eligible to join the TEAMMATE Trial.
References
- 1. Kirk R, Dipchand AI, Edwards LB, Kucheryavaya AY, Benden C, Christie JD, Dobbles F, Rahmel AO, Stehlik J, Hertz MI, International Society for H and Lung T. The Registry of the International Society for Heart and Lung Transplantation: fifteenth pediatric heart transplantation report--2012. J Heart Lung Transplant. 2012;31:1065-72.
- 2. Hoyer PF, Ettenger R, Kovarik JM, Webb NJ, Lemire J, Mentser M, Mahan J, Loirat C, Niaudet P, VanDamme-Lombaerts R, Offner G, Wehr S, Moeller V, Mayer H and Everolimus Pediatric Study G. Everolimus in pediatric de nova renal transplant patients. Transplantation. 2003;75:2082-5.
- 3. Sierra CM, Tan R, Eguchi J, Bailey L, Chinnock RE. Calcineurin inhibitor- and corticosteroid-free immunosuppression in pediatric heart transplant patients. Pediatr Transplant. 2017 Feb;21(1).
- 4. Rossano JW, Jefferies JL, Pahl E, Naftel DC, Pruitt E, Lupton K, Dreyer WJ, Chinnock R, Boyle G, Mahle WT; Pediatric Heart Transplant Study Investigators. Use of sirolimus in pediatric heart transplant patients: A multi-institutional study from the Pediatric Heart Transplant Study Group. J Heart Lung Transplant. 2017 Apr;36(4):427-433.
- 5. Almond CS, Hoen H, Rossano JW, Castleberry C, Auerbach SR, Yang L, Lal AK, Everitt MD, Fenton M, Hollander SA, Pahl E, Pruitt E, Rosenthal DN, McElhinney DB, Daly KP, Desai M; Pediatric Heart Transplant Study (PHTS) Group Registry. Development and validation of a major adverse transplant event (MATE) score to predict late graft loss in pediatric heart transplantation. J Heart Lung Transplant. 2017 Mar 24.
- 6. Castleberry C, Ziniel S, Almond C, Auerbach S, Hollander SA, Lal AK, Fenton M, Pahl E, Rossano JW, Everitt MD, Daly KP. Clinical practice patterns are relatively uniform between pediatric heart transplant centers: A survey-based assessment. Pediatr Transplant. 2017 Aug;21(5).