Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

The introduction of calcineurin inhibitors like tacrolimus has greatly reduced the incidence
of acute rejection, improving graft and patient survival after transplantation. However,
tacrolimus, one of the most widely used immunosuppressants and a mainstay of solid organ
transplantation, has a narrow therapeutic index and wide pharmacokinetic variability. As
such, there is a clear need for precision medicine to address post-transplant
immunosuppression.

The study team has developed a powerful platform [Phenotypic Precision Medicine (PPM)] that
utilizes patient-specific clinical data which represents each patient's response to drug
treatment. This platform can efficiently prescribe precise and optimized drug doses despite
the frequent changes to patient treatment regimens following transplantation. This
potentially can have a profound effect on drug metabolism.

The aim of this project is to use PPM to uncover valuable and previously unknown information
pertaining to patient dose requirements and correlate them with patient clinical and other
contextual information. This study is also expected to reveal vital patient subpopulation
information; and any future discovery of quantitative biomarkers as measures of
immunosuppression will serve as a gateway towards even more effective personalized and
relevant drug dosing.

Inclusion Criteria:

- adults undergoing liver and/or kidney transplantation

Exclusion Criteria:

- transplant patients with contraindications to tacrolimus