drugset / Trial / NCT03465410

OPTImization of the Dose of tacroliMUS by Bayesian Prediction

NCT03465410 ↗

Phase 4 Completed 96 enrolled NURIA LLOBERAS BLANCH
RandomizedParallel-groupOpen-labelTreatment

Summary

The pharmacokinetics of tacrolimus (TAC) are characterized by high inter- and intra-individual variability with narrow therapeutic range. Currently, the limiting point of Tac drug monitoring is the inability to individualize doses during the first few days after transplantation. Our group developed a population pharmacokinetic model (PPK) identifying CYP3A4 \* 22 and CYP3A5 \* 3 polymorphisms and hematocrit as explanatory variables of the observed variability in pre-dose (Co) concentrations. According to this model, the proportion of patients that do not reach the therapeutic target is 40

Timeline

Start
2017-03-21
Primary completion
2020-09-21
Completion
2020-09-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tacrolimus Small molecule — —

Indications

No indication recorded.