Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus through genetics will help in early attainment and maintenance of the correct dosage level in the early post-transplant period. This pilot dose-finding trial will help to determine a dosing strategy guided by genotypes and age for solid organ transplant recipients that will be further validated through a multi-centre trial as an immediate next step. The study hypothesizes that dosage levels determined through age and genotype will be attained faster and more accurately than the standard dosing procedures in the 14-days after the transplant. Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster recovery (tested through the kidneys' ability to clear creatine from the blood) and result in lower frequencies of adverse effects and rejection of the transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Age < 18 years old

• Assessed and/or listed for heart, kidney, liver transplantation

• Planned oral or enteral maintenance immunosuppression with tacrolimus post transplant

• Informed consent of legal guardian

Exclusion Criteria:

• Contra-indications to oral or enteral tacrolimus

• Co-morbidities that preclude standard dosing e.g. significant renal or hepatic insufficiency

• Participation in other investigational drug trials within 30 days of study initiation