Utilising Genotype Informed Bayesian Dosing of Tacrolimus in Children Post Solid Organ Transplantation.

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-18
SponsorMurdoch Childrens Research Institute

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

Treatment groups

45 Participants
are divided into 1 treatment group