About this trial
This study aims to evaluate the efficacy of genotype-informed Bayesian dosing of tacrolimus in optimising drug exposure among paediatric solid organ transplant recipients. By tailoring tacrolimus dosage based on individual genetic makeup and using Bayesian modeling to predict drug levels, the researchers hope to increase the likelihood of achieving therapeutic drug concentrations while minimising the risk of adverse events associated with subtherapeutic or supratherapeutic exposure.
Eligibility criteria
Qualifiers
Age 1-18 years of age
Kidney, liver or heart transplant recipients
Participant and/or parent consent to the study (prospective arm only)
Disqualifiers
Previous liver transplant.
Lung OR Intestinal transplant.
Insufficient time before transplant for pharmacogenomic analysis (prospective arm only)
Immunosuppressant regimen not containing tacrolimus immediate release product
Trial design
Treatments tested in this trial
- Genotyping for CYP3A4 and CYP3A5 genes
- Use of NextDose platform
- Tacrolimus