Ontology highlight
ABSTRACT:
SUBMITTER: Rubik J
PROVIDER: S-EPMC6852421 | biostudies-literature | 2019 Nov
REPOSITORIES: biostudies-literature
Rubik Jacek J Debray Dominique D Kelly Deirdre D Iserin Franck F Webb Nicholas J A NJA Czubkowski Piotr P Vondrak Karel K Sellier-Leclerc Anne-Laure AL Rivet Christine C Riva Silvia S Tönshoff Burkhard B D'Antiga Lorenzo L Marks Stephen D SD Reding Raymond R Kazeem Gbenga G Undre Nasrullah N
Transplant international : official journal of the European Society for Organ Transplantation 20190827 11
There are limited clinical data regarding prolonged-release tacrolimus (PR-T) use in pediatric transplant recipients. This Phase 2 study assessed the efficacy and safety of PR-T in stable pediatric kidney, liver, and heart transplant recipients (aged ≥5 to ≤16 years) over 1 year following conversion from immediate-release tacrolimus (IR-T), on a 1:1 mg total-daily-dose basis. Endpoints included the incidence of acute rejection (AR), a composite endpoint of efficacy failure (death, graft loss, bi ...[more]