Clinical trial NCT00189826: A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.
Official title: A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With Steroids in Patients Undergoing Primary Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Transplantation
Keywords: Tacrolimus
Liver transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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..

Primary outcomes:
measure: Incidence of and time to biopsy-proven acute rejections
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of acute rejections
timeFrame: 12 months
Other outcomes:
Locations:
city: Heidelberg
country: Australia
city: Sydney
country: Australia
city: Gent
country: Belgium
city: Liege
country: Belgium
city: Bel Horizonte
country: Brazil
city: Porto Alegre
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Praha 4
country: Czech Republic
city: Helsinki
country: Finland
city: Clichy
country: France
city: Creteil
country: France
city: Lyon Cedex 03
country: France
city: Montpellier Cedex 05
country: France
city: Rennes Cedex
country: France
city: Strasbourg
country: France
city: Toulouse Cedex 9
country: France
city: Villejuif
country: France
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Regensburg
country: Germany
city: Dublin 4
country: Ireland
city: Bergamo
country: Italy
city: Bologna
country: Italy
city: Genova
country: Italy
city: Modena
country: Italy
city: Palermo
country: Italy
city: Udine
country: Italy
city: Oslo
country: Norway
city: Warsaw
country: Poland
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Santiago de Compostela
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Goteborg
country: Sweden
city: Stockholm
country: Sweden
city: Bern
country: Switzerland
city: Zurich
country: Switzerland
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
Study officials:
affiliation: Charite Campus Virchow Klinikum
name: J. Langrehr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.