Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
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.
Timeline
- Start
- 2011-09
- Primary completion
- 2016-02
- Completion
- 2016-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tacrolimus | Small molecule | 0.075 mg/kg | — |
| Subject | Tacrolimus | Small molecule | 0.1 mg/kg | — |
| Subject | Tacrolimus | Small molecule | 0.15 mg/kg | — |
| Subject | Tacrolimus | Small molecule | 0.2 mg/kg | — |
Indications
No indication recorded.