Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 u...
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 / st...
Eligibility Criteria
Inclusion
- Patients receiving a primary, split liver or a whole liver graft from a cadaveric donor with compatible ABO blood type.
Exclusion
- 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..
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT00189826
Start Date
August 1 2004
End Date
December 1 2006
Last Update
July 9 2014
Active Locations (51)
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1
Heidelberg, Australia, VIC 3084
2
Sydney, Australia, 2050
3
Ghent, Belgium, 9000
4
Liège, Belgium, 4000