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

Astellas

Status and phase: Completed; Phase 3

Conditions: Liver Transplantation

Treatments: Drug: tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189826

FG-506E-11-03

Details and patient eligibility

About

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.

Full description

A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a dual modified release FK506E (MR4) / steroid regimen with a standard tacrolimus FK506 / steroid regimen.

Enrollment: 475 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients receiving a primary, split liver or a whole liver graft from a cadaveric donor with compatible ABO blood type.

Exclusion criteria

• Patients receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation).
• Patients with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus.
• Patients with serum creatinine > 200 µmol/l..

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

475 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: tacrolimus

2

Experimental group

Treatment:

Drug: tacrolimus