Article ; Online: The teammate trial: Study design and rationale tacrolimus and everolimus against tacrolimus and MMF in pediatric heart transplantation using the major adverse transplant event (MATE) score.
2023 Volume 260, Page(s) 100–112
Abstract: Background: Currently there are no immunosuppression regimens FDA-approved to prevent rejection in pediatric heart transplantation (HT). In recent years, everolimus (EVL) has emerged as a potential alternative to standard tacrolimus (TAC) as the primary ...
| Abstract | Background: Currently there are no immunosuppression regimens FDA-approved to prevent rejection in pediatric heart transplantation (HT). In recent years, everolimus (EVL) has emerged as a potential alternative to standard tacrolimus (TAC) as the primary immunosuppressant to prevent rejection that may also reduce the risk of cardiac allograft vasculopathy (CAV), chronic kidney disease (CKD) and cytomegalovirus (CMV) infection. However, the 2 regimens have never been compared head-to-head in a randomized trial. The study design and rationale are reviewed in light of the challenges inherent in rare disease research. Methods: The TEAMMATE trial (IND 127980) is the first multicenter randomized clinical trial (RCT) in pediatric HT. The primary purpose is to evaluate the safety and efficacy of EVL and low-dose TAC (LD-TAC) compared to standard-dose TAC and mycophenolate mofetil (MMF). Children aged <21 years at HT were randomized (1:1 ratio) at 6 months post-HT to either regimen, and followed for 30 months. Children with recurrent rejection, multi-organ transplant recipients, and those with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m Conclusion: The TEAMMATE trial is the first multicenter RCT in pediatric HT. It is anticipated that the study will provide important information about the safety and efficacy of everolimus vs tacrolimus-based regimens and will provide valuable lessons into the design and conduct of future trials in pediatric HT. |
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| MeSH term(s) | Humans ; Child ; Tacrolimus/therapeutic use ; Tacrolimus/pharmacology ; Everolimus/pharmacology ; Mycophenolic Acid/therapeutic use ; Mycophenolic Acid/pharmacology ; Kidney Transplantation/adverse effects ; Immunosuppressive Agents/therapeutic use ; Immunosuppressive Agents/pharmacology ; Heart Transplantation ; Renal Insufficiency, Chronic/etiology ; Heart Diseases/etiology ; Drug Therapy, Combination ; Graft Survival | |||||
| Chemical Substances | Tacrolimus (WM0HAQ4WNM) ; Everolimus (9HW64Q8G6G) ; Mycophenolic Acid (HU9DX48N0T) ; Immunosuppressive Agents | |||||
| Language | English | |||||
| Publishing date | 2023-02-23 | |||||
| Publishing country | United States | |||||
| Document type | Randomized Controlled Trial ; Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S. | |||||
| ZDB-ID | 80026-0 | |||||
| ISSN | 1097-6744 ; 0002-8703 | |||||
| ISSN (online) | 1097-6744 | |||||
| ISSN | 0002-8703 | |||||
| DOI | 10.1016/j.ahj.2023.02.002 | |||||
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| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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