A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation

Phase 4 Completed 100 enrolled Astellas Pharma Inc

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.

Timeline

Start: 2011-04-27
Primary completion: 2014-05-27
Completion: 2014-05-27

Publications

Shin MH, Song GW, Lee SG, Hwang S, Kim KH, Ahn CS, Moon DB, Ha TY, Jung DH, Park GC, Yun YI, Kim WJ, Kang WH, Kim SH, Jiang H, Lee S, Tak EY. 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. Clin Transplant. 2018 Sep;32(9):e13376. doi: 10.1111/ctr.13376. Epub 2018 Aug 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tacrolimus	Small molecule	—	Oral

Indications

No indication recorded.