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

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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

Trial contacts and locations

51

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Data sourced from clinicaltrials.gov

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