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- Title
Comparative pharmacokinetics of tacrolimus in de novo pediatric transplant recipients randomized to receive immediate‐ or prolonged‐release tacrolimus.
- Authors
Vondrak, Karel; Dhawan, Anil; Parisi, Francesco; Grenda, Ryszard; Debray, Dominique; Marks, Stephen D.; Webb, Nicholas J. A.; Lachaux, Alain; Kazeem, Gbenga; Undre, Nasrullah
- Abstract
Phase 2, parallel‐group, multicenter, open‐label, 4‐week study, comparing PK of PR‐T vs IR‐T in de novo pediatric patients undergoing primary kidney, liver, or heart transplantation. Patients randomized 1:1 to receive once daily, PR‐T‐, or twice‐daily, IR‐T‐based regimens; dose adjustments permitted after Day 1. Twenty‐four‐hour PK profiles collected on Days 1, 7, and 28. Primary endpoint: tacrolimus AUC24. Secondary end points included tacrolimus C24 and Cmax. Endpoints compared between PR‐T and IR‐T on Days 1, 7, and 28. Predefined similarity interval for CIs of LSM ratios: 80%‐125%. PK analysis set comprised 33 patients (PR‐T, n = 15; IR‐T, n = 18). Overall, AUC24 and Cmax were lower on Day 1 vs 7 and 28. Geometric LSM ratios of PR‐T:IR‐T on Days 1, 7, and 28 were 66.3%, 92.5%, 99.9%, respectively, for AUC24; 66.3%, 82.2%, 90.9% for C24; and 77.3%, 120.3%, 92.2% for Cmax. AUC24 90% CI within predefined similarity interval on Day 28; other 90% CIs fell outside. Linear relationship was similar between AUC24 and C24, and between tacrolimus formulations, suggesting that the same therapeutic drug monitoring method can be used with both formulations in de novo pediatric allograft recipients.
- Subjects
PHARMACOKINETICS; TACROLIMUS; CHILD patients; LIVER transplantation; HEART transplantation
- Publication
Pediatric Transplantation, 2018, Vol 22, Issue 8, pN.PAG
- ISSN
1397-3142
- Publication type
Article
- DOI
10.1111/petr.13289