Once-daily, prolonged-release tacrolimus vs twice-daily, immediate-release tacrolimus in de novo living-donor liver transplantation: A Phase 4, randomized, open-label, comparative, single-center study
- Authors
- Shin M.-H.; Song G.-W.; Lee S.-G.; Hwang S.; Kim K.-H.; Ahn C.-S.; Moon D.-B.; Ha T.-Y.; Jung D.-H.; Park G.-C.; Yun Y.-I.; Kim W.-J.; Kang W.-H.; Kim S.-H.; Jiang H.; Lee S.; Tak E.-Y.
- Issue Date
- Sep-2018
- Publisher
- Blackwell Publishing Ltd
- Keywords
- calcineurin inhibitor; immunosuppressant; liver transplantation; living donor; pharmacokinetics/pharmacodynamics; prolonged-release tacrolimus; tacrolimus
- Citation
- Clinical Transplantation, v.32, no.9
- Indexed
- SCI
SCIE
SCOPUS
- Journal Title
- Clinical Transplantation
- Volume
- 32
- Number
- 9
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/43396
- DOI
- 10.1111/ctr.13376
- ISSN
- 0902-0063
1399-0012
- Abstract
- Randomized, open-label, comparative, single-center, Phase 4, 24-week study comparing pharmacokinetics (PK), safety, and efficacy of once-daily, prolonged-release tacrolimus (PR-T) with twice-daily, immediate-release tacrolimus (IR-T) in adult de novo living-donor liver transplant (LDLT) recipients in Korea. All patients received intravenous tacrolimus from Day 0 (transplantation) for 4 days and were randomized (1:1) to receive oral PR-T or IR-T from Day 5. PK profiles were taken on Days 6 and 21. Primary endpoint: area under the concentration-time curve over 24 hour (AUC0-24). Predefined similarity interval for confidence intervals of ratios: 80%-125%. Secondary endpoints included: tacrolimus concentration at 24 hour (C24), patient/graft survival, biopsy-confirmed acute rejection (BCAR), treatment-emergent adverse events (TEAEs). One-hundred patients were included (PR-T, n = 50; IR-T, n = 50). Compared with IR-T, 40% and 66% higher mean PR-T daily doses resulted in similar AUC0-24 between formulations on Day 6 (PR-T:IR-T ratio of means 96.8%), and numerically higher AUC0-24 with PR-T on Day 21 (128.8%), respectively. Linear relationship was similar between AUC0-24 and C24, and formulations. No graft loss/deaths, incidence of BCAR and TEAEs similar between formulations. Higher PR-T vs IR-T doses were required to achieve comparable systemic exposure in Korean de novo LDLT recipients. PR-T was efficacious; no new safety signals were detected. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
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Collections - 5. Others > Others(Medicine) > 1. Journal Articles
- 2. Clinical Science > Department of Hepato-Biliary-Pancreatic Surgery > 1. Journal Articles
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