In:
Pediatric Transplantation, Wiley, Vol. 22, No. 8 ( 2018-12)
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 AUC 24 . Secondary end points included tacrolimus C 24 and C max . Endpoints compared between PR ‐T and IR ‐T on Days 1, 7, and 28. Predefined similarity interval for CI s of LSM ratios: 80%‐125%. PK analysis set comprised 33 patients ( PR ‐T, n = 15; IR ‐T, n = 18). Overall, AUC 24 and C max 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 AUC 24 ; 66.3%, 82.2%, 90.9% for C 24 ; and 77.3%, 120.3%, 92.2% for C max . AUC 24 90% CI within predefined similarity interval on Day 28; other 90% CI s fell outside. Linear relationship was similar between AUC 24 and C 24 , and between tacrolimus formulations, suggesting that the same therapeutic drug monitoring method can be used with both formulations in de novo pediatric allograft recipients.
Type of Medium:
Online Resource
ISSN:
1397-3142
,
1399-3046
DOI:
10.1111/petr.2018.22.issue-8
Language:
English
Publisher:
Wiley
Publication Date:
2018
detail.hit.zdb_id:
2008614-3
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