Electronic Patient File-Embedded Model-Informed Precision Dosing Compared with Physician Dosing of Tacrolimus in Kidney Transplantation.

ABSTRACT: Model-informed precision dosing (MIPD) of tacrolimus in renal allograft recipients, evaluated in silico, demonstrated improved (time to and) probability of target concentration attainment and smaller deviations from target range. Using simulated tacrolimus concentration-time profiles, a study of 200 patients was predicted to have sufficient power to demonstrate superior performance of MIPD for these exposure end points compared with physician-based dosing. A fully automated tacrolimus MIPD application integrated in the electronic patient file was tested in 293 de novo recipients in the first 14 days after transplantation in a prospective randomized controlled clinical validation study. More patients dosed with the MIPD application reached the primary study end point of three in-target tacr

SUBMITTER: Kuypers DRJ 

PROVIDER: S-EPMC12816423 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature