A non-linear mixed effects model describing tacrolimus exposure in pregnant and non-pregnant subjects will be developed using prospectively collected de-identified data from pregnant uterus transplant recipients at BUMC.
The model will be analyzed to develop an estimating equation for tacrolimus unbound concentrations from whole blood concentrations, albumin and hematocrit during each trimester of pregnancy.
The estimating equation will then be applied to data from uterus transplant recipients enrolled in this study and retrospectively to uterus recipients transplanted since October 2020 to clinically validate the findings.