A prospective validation of a population pharmacokinetic model of tacrolimus in Tunisian kidney transplant patients

A prospective validation of pharmacokinetic population (Pk pop) of Tacrolimus (Tac) for dose adjustment in kidney transplant patients was assessed in only one study. The present study was aimed at prospectively evaluating the performance of our previously developed Tac- Pk pop model in predicting trough concentration (C0) in Tunisian kidney transplant patients. It was a prospective study including patients who had undergone kidney transplantation at Monastir-Nephrology Department. The population study was divided into adherence and control groups. A total of 198 C0 (30 patients) were analyzed. The proportion of C0 within TR was 63.9% and 38.0% in the adhesion and control group, respectively. The percentage of C0 within TR was significantly higher in the adherence group during both early and late post-transplant period (p = 0.03 and 0.04, respectively). This percentage was found to be significantly higher during the third C0 monitoring and thereafter in the adherence group compared with the control group (65.8% vs 41%, respectively). Tac dose proposal based on this model could be helpful to improve clinical outcomes in our population by reducing the risk of acute rejection and this immunosuppressant's toxic side effects. •To our knowledge, this is the second study evaluating prospectively Tac dose adjustment by the Bayesian estimates after renal transplantation.•Our model was efficient in predicting Tac dose requirement during both, early and late post-transplantation phases.•Patients benefiting from Tac dose adjustment based on the present Pk-pop model were roughly two folds more prone to have Tac C0 within target ranges.