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Comparative pharmacokinetics of tacrolimus in stable pediatric allograft recipients converted from immediate-release tacrolimus to prolonged-release tacrolimus formulation

This study was a Phase II, open-label, multicenter, single-arm, cross-over study comparing the pharmacokinetics (PK) of tacrolimus in stable pediatric kidney, liver, or heart allograft recipients converted from immediate-release tacrolimus (IR-T) to prolonged-release tacrolimus (PR-T). In Days −30 t...

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Main Authors: Rubik, Jacek (Author) , Debray, Dominique (Author) , Iserin, Franck (Author) , Vondrak, Karel (Author) , Sellier‐Leclerc, Anne-Laure (Author) , Kelly, Deirdre (Author) , Czubkowski, Piotr (Author) , Webb, Nicholas J. A. (Author) , Riva, Silvia (Author) , D'Antiga, Lorenzo (Author) , Marks, Stephen D. (Author) , Rivet, Christine (Author) , Tönshoff, Burkhard (Author) , Kazeem, Gbenga (Author) , Undre, Nasrullah (Author)
Format: Article (Journal)
Language:English
Published: 1 February 2019
In: Pediatric transplantation
Year: 2019, Volume: 23, Issue: 4, Pages: e13391
ISSN:1399-3046
DOI:10.1111/petr.13391
Online Access:Verlag, Volltext: https://doi.org/10.1111/petr.13391
Verlag, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/petr.13391
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Author Notes:Jacek Rubik, Dominique Debray, Franck Iserin, Karel Vondrak, Anne-Laure Sellier‐Leclerc, Deirdre Kelly, Piotr Czubkowski, Nicholas J. A. Webb, Silvia Riva, Lorenzo D'Antiga, Stephen D. Marks, Christine Rivet, Burkhard Tönshoff, Gbenga Kazeem, Nasrullah Undre
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Summary:This study was a Phase II, open-label, multicenter, single-arm, cross-over study comparing the pharmacokinetics (PK) of tacrolimus in stable pediatric kidney, liver, or heart allograft recipients converted from immediate-release tacrolimus (IR-T) to prolonged-release tacrolimus (PR-T). In Days −30 to −1 of screening period, patients received their IR-T-based regimen; during Days 1-7, patients received study IR-T (same dose as screening). On Day 7, the first 24-hours PK profile was taken; patients were then converted to PR-T (1 mg:1 mg), with a second 24-hours PK profile taken on Day 14. The primary end-point was tacrolimus area under the blood concentration-time curve over 24 hours (AUC24); secondary end-points were maximum concentration Cmaxand concentration at 24 hours C24. The predefined similarity interval for confidence intervals (CIs) of least squares mean (LSM) ratios was 80%-125%. The PK analysis set comprised 74 pediatric transplant recipients (kidney, n = 45; liver, n = 28; heart, n = 1). PR-T:IR-T LSM ratio (90% CI) was similar overall for AUC24, max, and C24, and for kidney and liver recipients for AUC24 (LSM ratio, kidney 91.8%; liver 104.1%) and C24 (kidney 90.5%; liver 89.9%). Linear relationship was similar between AUC24 and C24, and between PR-T and IR-T (rho 0.89 and 0.84, respectively), suggesting that stable pediatric transplant recipients can be converted from IR-T to PR-T at the same total daily dose, using the same therapeutic drug monitoring method.
Item Description:Gesehen am 14.02.2020
Physical Description:Online Resource
ISSN:1399-3046
DOI:10.1111/petr.13391

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