NCT06529536 Utilising Genotype Informed Bayesian Dosing of Tacrolimus in Children Post Solid Organ Transplantation.
| NCT ID | NCT06529536 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Murdoch Childrens Research Institute |
| Condition | Solid Organ Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 45 participants in total. It began in 2024-08-05 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Rachel Conyers
PRINCIPAL INVESTIGATOR
Murdoch Childrens Research Institute
Frequently Asked Questions
Who can join the NCT06529536 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Solid Organ Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06529536 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06529536 currently recruiting?
Yes, NCT06529536 is actively recruiting participants. Contact the research team at pharmaco.genomics@mcri.edu.au for enrollment information.
Where is the NCT06529536 trial being conducted?
This trial is being conducted at Melbourne, Australia.
Who is sponsoring the NCT06529536 clinical trial?
NCT06529536 is sponsored by Murdoch Childrens Research Institute. The principal investigator is Rachel Conyers at Murdoch Childrens Research Institute. The trial plans to enroll 45 participants.