Status:
RECRUITING
Utilising Genotype Informed Bayesian Dosing of Tacrolimus in Children Post Solid Organ Transplantation.
Lead Sponsor:
Murdoch Childrens Research Institute
Conditions:
Solid Organ Transplant
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
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 dosa...
Detailed Description
Tacrolimus, a calcineurin inhibitor is an effective immunosuppressant for solid organ transplants (SOT). Due to its narrow therapeutic index and individual variability in its pharmacokinetics (PK), th...
Eligibility Criteria
Inclusion
- 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) and who will be on tacrolimus as one of the main immunosuppressants post-transplant.
- 1 to 18years old
- SOT transplant (planned or on waiting list).
- Heart OR Liver OR Renal transplant recipients
- Amenable to venepuncture and blood draw
- Patient and/or parent consented to the study.
Exclusion
- older than 18 year old
- younger than 1 year old
- Previous liver transplant.
- Lung OR Intestinal transplant.
- Insufficient time before transplant for pharmacogenomic analysis (prospective arm only)
- Patient has a known hypersensitivity to tacrolimus and/or its formulation.
- On a slow release preparation of Tacrolimus (e.g Advagraf extended release Brand)
- Immunosuppressant regimen not containing tacrolimus immediate release product
- Patient and/or parent is unable to consent to the study.
- Patient and/or parent is unwilling to take part in the study.
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 2 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06529536
Start Date
August 5 2024
End Date
August 2 2027
Last Update
September 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Children's Hospital
Melbourne, Victoria, Australia, 3052