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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00189826




Registration number
NCT00189826
Ethics application status
Date submitted
13/09/2005
Date registered
19/09/2005
Date last updated
9/07/2014

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.
Scientific 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
Secondary ID [1] 0 0
FG-506E-11-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tacrolimus

Active Comparator: 1 -

Experimental: 2 -


Treatment: Drugs: tacrolimus
immunosuppression
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of and time to biopsy-proven acute rejections
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Incidence of acute rejections
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
- Patients receiving a primary, split liver or a whole liver graft from a cadaveric
donor with compatible ABO blood type.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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..

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
475
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Heidelberg
Recruitment hospital [2] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
VIC 3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Gent
Country [2] 0 0
Belgium
State/province [2] 0 0
Liege
Country [3] 0 0
Brazil
State/province [3] 0 0
Bel Horizonte
Country [4] 0 0
Brazil
State/province [4] 0 0
Porto Alegre
Country [5] 0 0
Brazil
State/province [5] 0 0
Rio de Janeiro
Country [6] 0 0
Brazil
State/province [6] 0 0
Sao Paulo
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
British Columbia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Praha 4
Country [12] 0 0
Finland
State/province [12] 0 0
Helsinki
Country [13] 0 0
France
State/province [13] 0 0
Clichy
Country [14] 0 0
France
State/province [14] 0 0
Creteil
Country [15] 0 0
France
State/province [15] 0 0
Lyon Cedex 03
Country [16] 0 0
France
State/province [16] 0 0
Montpellier Cedex 05
Country [17] 0 0
France
State/province [17] 0 0
Rennes Cedex
Country [18] 0 0
France
State/province [18] 0 0
Strasbourg
Country [19] 0 0
France
State/province [19] 0 0
Toulouse Cedex 9
Country [20] 0 0
France
State/province [20] 0 0
Villejuif
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Hamburg
Country [23] 0 0
Germany
State/province [23] 0 0
Heidelberg
Country [24] 0 0
Germany
State/province [24] 0 0
Regensburg
Country [25] 0 0
Ireland
State/province [25] 0 0
Dublin 4
Country [26] 0 0
Italy
State/province [26] 0 0
Bergamo
Country [27] 0 0
Italy
State/province [27] 0 0
Bologna
Country [28] 0 0
Italy
State/province [28] 0 0
Genova
Country [29] 0 0
Italy
State/province [29] 0 0
Modena
Country [30] 0 0
Italy
State/province [30] 0 0
Palermo
Country [31] 0 0
Italy
State/province [31] 0 0
Udine
Country [32] 0 0
Norway
State/province [32] 0 0
Oslo
Country [33] 0 0
Poland
State/province [33] 0 0
Warsaw
Country [34] 0 0
Spain
State/province [34] 0 0
Barakaldo
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Cordoba
Country [37] 0 0
Spain
State/province [37] 0 0
Santiago de Compostela
Country [38] 0 0
Spain
State/province [38] 0 0
Sevilla
Country [39] 0 0
Spain
State/province [39] 0 0
Valencia
Country [40] 0 0
Sweden
State/province [40] 0 0
Goteborg
Country [41] 0 0
Sweden
State/province [41] 0 0
Stockholm
Country [42] 0 0
Switzerland
State/province [42] 0 0
Bern
Country [43] 0 0
Switzerland
State/province [43] 0 0
Zurich
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Leeds
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Astellas Pharma Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00189826
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
J. Langrehr
Address 0 0
Charite Campus Virchow Klinikum
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries