Vondrak, K;
Dhawan, A;
Parisi, F;
Grenda, R;
Debray, D;
Marks, SD;
Webb, NJA;
... Undre, N; + view all
(2018)
Comparative pharmacokinetics of tacrolimus in de novo pediatric transplant recipients randomized to receive immediate- or prolonged-release tacrolimus.
Pediatric Transplantation
, 22
(8)
, Article e13289. 10.1111/petr.13289.
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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.
| Type: | Article |
|---|---|
| Title: | Comparative pharmacokinetics of tacrolimus in de novo pediatric transplant recipients randomized to receive immediate- or prolonged-release tacrolimus |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1111/petr.13289 |
| Publisher version: | https://doi.org/10.1111/petr.13289 |
| Language: | English |
| Additional information: | This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes https://creativecommons.org/licenses/by-nc/4.0/ |
| Keywords: | heart transplantation, kidney transplantation, liver transplantation, pediatrics, pharmacokinetics, tacrolimus |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10068711 |
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