Tacrolimus therapeutic drug monitoring is challenging due to high inter- and intra-patient variability. A prospective randomized controlled trial was conducted by researchers at the University Hospital in Leuven, Belgium, on 293 de novo kidney transplant recipients during the first 14 days post-transplant. A fully automated Model-informed precision dosing (MIPD) application (1) was integrated into the electronic patient record and compared with standard physician-based dosing.
Key Findings
- Automated Model-informed precision dosing significantly outperformed traditional physician-based dosing for achieving tacrolimus target concentrations
- Model-informed precision dosing patients spent more time within therapeutic range with smaller deviations from target
- The system was well-accepted by physicians, with minimal override of recommendations
- Full integration into electronic health records enabled seamless clinical workflow
Clinical Implications
This study provides proof-of-concept that fully automated, algorithm-driven tacrolimus dosing can improve therapeutic drug monitoring in real-world clinical practice. The superior performance in achieving target exposure levels could potentially translate to better clinical outcomes (reduced rejection, toxicity, and graft loss), warranting larger trials to evaluate the impact of Model-informed precision dosing on long-term patient and graft survival.
Next Steps
The authors recommend larger clinical trials to assess whether improved tacrolimus exposure control with Model-informed precision dosing translates into:
- Reduced acute rejection episodes
- Lower toxicity rates (nephrotoxicity, NODAT, neurotoxicity)
- Improved long-term graft survival
- Better patient outcomes overall
Read more at this link on Clinical Pharmacology and Therapeutics
Footnotes
(1) Model-Informed Precision Dosing uses computer algorithms to help doctors calculate the optimal medication dose for each individual patient.
Citation
Electronic Patient File-Embedded Model-Informed Precision Dosing Compared with Physician Dosing of Tacrolimus in Kidney Transplantation, Dirk R.J. Kuypers, Pieter Annaert, Borefore Jallah, Maarten Naesens, Maxine Teuns, Annouschka Laenen, Ruben Faelens, First published: 11 October 2025, https://doi.org/10.1002/cpt.70090