{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["24(1)"],"submitter":["Wohl DS"],"funding":["Chiesi Foundation","Universitätsklinikum Regensburg"],"pubmed_abstract":["<h4>Background</h4>Graft rejection and chronic CNI toxicity remain obstacles to organ transplant success. Current formulations of tacrolimus, such as Prograf® and Advagraf™, exhibit limitations in terms of pharmacokinetics and tolerability, related in part to suboptimal bioavailability. As dosing non-compliance can result in graft rejection, the once daily formulation of tacrolimus, Advagraf™, was developed (vs 2x/day Prograf®). Benefits of Advagraf™ are counterbalanced by delayed achievement of therapeutic trough levels and need for up to 50% higher doses to maintain Prograf®-equivalent troughs. Envarsus® is also a prolonged-release once-daily tacrolimus formulation, developed using MeltDose™ drug-delivery technology to increase drug bioavailability; improved bioavailability results in lo"],"journal":["Trials"],"pagination":["325"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10176804"],"repository":["biostudies-literature"],"pubmed_title":["EnGraft: a multicentre, open-label, randomised, two-arm, superiority study protocol to assess bioavailability and practicability of Envarsus® versus Advagraf™ in liver transplant recipients."],"pmcid":["PMC10176804"],"pubmed_authors":["Gotz M","Braun F","Vondran FWR","Geissler EK","James B","Holub-Hayles I","Pratschke J","EnGraft Trial Group","Herden U","Mittler J","Croner R","Brennfleck F","Schnitzbauer AA","Vogel T","Wohl DS","Willuweit K","Berg T","Mutzbauer I","Schlitt HJ","Brunner SM","Nadalin S","Baccar S","Merle U","Neumann UP","Rauchfuß F"],"additional_accession":[]},"is_claimable":false,"name":"EnGraft: a multicentre, open-label, randomised, two-arm, superiority study protocol to assess bioavailability and practicability of Envarsus® versus Advagraf™ in liver transplant recipients.","description":"<h4>Background</h4>Graft rejection and chronic CNI toxicity remain obstacles to organ transplant success. Current formulations of tacrolimus, such as Prograf® and Advagraf™, exhibit limitations in terms of pharmacokinetics and tolerability, related in part to suboptimal bioavailability. As dosing non-compliance can result in graft rejection, the once daily formulation of tacrolimus, Advagraf™, was developed (vs 2x/day Prograf®). Benefits of Advagraf™ are counterbalanced by delayed achievement of therapeutic trough levels and need for up to 50% higher doses to maintain Prograf®-equivalent troughs. Envarsus® is also a prolonged-release once-daily tacrolimus formulation, developed using MeltDose™ drug-delivery technology to increase drug bioavailability; improved bioavailability results in lo","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 May","modification":"2025-04-04T20:00:15.935Z","creation":"2024-11-13T02:32:11.401Z"},"accession":"S-EPMC10176804","cross_references":{"pubmed":["37170284"],"doi":["10.1186/s13063-023-07344-7"]}}