A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.
- Registration Number
- NCT00189826
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 475
Inclusion Criteria
- Patients receiving a primary, split liver or a whole liver graft from a cadaveric donor with compatible ABO blood type.
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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..
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 tacrolimus - 2 tacrolimus -
- Primary Outcome Measures
Name Time Method Incidence of and time to biopsy-proven acute rejections 12 months
- Secondary Outcome Measures
Name Time Method Incidence of acute rejections 12 months