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

RecruitingPhase 4Ages 1 Year - 18 YearsAllMurdoch Childrens Research Institute
NCT06529536 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Participants will be assigned to the prospective arm if treated at Royal Children's Hospital who are receiving a solid organ transplant (SOT) (excluding repeat graft in liver transplant recipients, or lung or intestinal transplant) and who will be on tacrolimus as one of the main immunosuppressants post-transplant. Inclusion Criteria: * Age 1-18 years of age * Kidney, liver or heart transplant recipients * Participant and/or parent consent to the study (prospective arm only) Exclusion Criteria: * 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 * Known hypersensitivity to tacrolimus and/or its formulation.
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What it tests

  • Genotyping for CYP3A4 and CYP3A5 genes
  • Use of NextDose platform
  • Tacrolimus
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Where

1 site
Royal Children's Hospital
Melbourne, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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