drugset / Trial / NCT03465410
OPTImization of the Dose of tacroliMUS by Bayesian Prediction
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tacrolimus | Small molecule | — | — |
Indications
No indication recorded.