Genotype-informed dosing of tacrolimus for children after organ transplants
Genotype Informed Bayesian Dosing of Tacrolimus in Solid Organ Transplant- Pharmacogenomic Implementation in Children
PHASE4 · Murdoch Childrens Research Institute · NCT06529536
This study tests if adjusting the dose of tacrolimus based on children's genetic makeup can help them after organ transplants by ensuring they get the right amount of the medication.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Murdoch Childrens Research Institute (other) |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT06529536 on ClinicalTrials.gov |
What this trial studies
This study evaluates how tailoring tacrolimus dosage based on genetic makeup can optimize drug exposure in pediatric solid organ transplant recipients. By using Bayesian modeling to predict drug levels, the researchers aim to achieve therapeutic drug concentrations while minimizing adverse events. Participants will undergo genotyping for CYP3A4 and CYP3A5 enzymes to guide tacrolimus dosing before and after transplantation. The goal is to improve treatment outcomes and reduce the risk of acute rejection associated with improper drug levels.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 18 years who are receiving a solid organ transplant and will be treated with tacrolimus.
Not a fit: Patients older than 18 years, younger than 1 year, or those who have had a previous liver transplant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer immunosuppressant therapy for children undergoing solid organ transplantation.
How similar studies have performed: Other studies have shown promise in using genotype-informed dosing strategies, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Melbourne, Victoria
- Royal Children's Hospital — Melbourne, Victoria, Australia (RECRUITING)
Study contacts
- Principal investigator: Rachel Conyers — Murdoch Childrens Research Institute
- Study coordinator: Rachel Conyers
- Email: pharmaco.genomics@mcri.edu.au
- Phone: 03 9936 6770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Organ Transplant, Tacrolimus, Pharmacogenomics, Bayesian, Paediatrics