Multicenter Randomized Trial of Everolimus in Pediatric Heart Transplantation
Abstract
This research proposes to conduct a randomized trial with children who have undergone recent heart transplant 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 ultimate public health goals of this study are (1) to improve the long-term safety and survival of children after heart transplant and (2) to obtain Food and Drug Administration (FDA) approval of the first anti-rejection medicine for pediatric heart transplant. The evaluation of medicines that prevent rejection in heart transplantation may have medical applications for treating military injuries that require vascular composite transplantation, such as hand transplantation. Furthermore, the class of treatment under study is uniquely known for its ability to alter wound-healing of human tissues and therefore may provide insights into the mechanistic pathways necessary to expedite wound healing.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1710532
Entities
People
- Lynn A Sleeper
Organizations
- United States Army