Phase 2
Completed N=53
Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
Source: ClinicalTrials.gov NCT01655563 ↗Enrolled (actual)
53
Serious AEs
9.4%
Results posted
Aug 2019
Primary outcomePrimary: Time to Achieve Therapeutic Tacrolimus Drug Concentrations — 4.7; 3.4 Days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Achieve Therapeutic Tacrolimus Drug Concentrations |
4.7; 3.4 | — |
| PRIMARY Time to Maintain Stable Therapeutic Trough Concentrations |
NA; 18 | — |
| SECONDARY Clinical Adverse Events |
71; 121 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01655563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.