A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.

Phase 3 Completed 475 enrolled Astellas Pharma Inc

RandomizedParallel-groupQuadruple-blindPrevention

Summary

To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

Timeline

Start: 2004-08
Primary completion: 2006-12
Completion: 2006-12

Publications

Ericzon BG, Varo E, Trunecka P, Fischer L, Colledan M, Gridelli B, Valdivieso A, O'Grady J, Dickinson J, Undre N. Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver transplantation: A randomized phase III substudy. Clin Transplant. 2017 Jun;31(6). doi: 10.1111/ctr.12958. Epub 2017 Apr 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tacrolimus	Small molecule	0.1 mg/kg	Oral
Subject	Tacrolimus	Small molecule	0.2 mg/kg	Oral

Indications

No indication recorded.