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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00189839




Registration number
NCT00189839
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 Kidney 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 MMF (Cellcept®) and Steroids in Patients Undergoing Kidney Transplantation
Secondary ID [1] 0 0
FG-506E-12-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney 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
Time to and incidence of biopsy-proven acute rejections
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Overall rate of acute rejections
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
* Patients receiving a kidney transplant from a cadaveric donor or a living non HLA identical donor between 5 and 65 years of age with compatible ABO blood type.
* Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or re-transplantation (unless the graft was lost because of immunological reasons within 12 months).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients receiving or having previously received an organ transplant other than a kidney.
* Patients with a high immunological risk, defined as a panel reactive antibodies (PRA) grade >50% in the previous 6 months and/or with a previous graft survival of less than 12 months due to immunological reasons.
* Cold ischaemia time of the donor kidney >30 hours.

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?



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
699
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Melbourne
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- Westmead
Recruitment hospital [4] 0 0
- Woudville South
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Woudville South
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
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Argentina
State/province [2] 0 0
Santa Fe
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Austria
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Innsbruck
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Belgium
State/province [4] 0 0
Bruxelles
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Belgium
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Leuven
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Brazil
State/province [6] 0 0
Campinas - SP
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro - RJ
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Brazil
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San Paulo - SP
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Czech Republic
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Praha 4
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Finland
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Helsinki
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France
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Creteil
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France
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Grenoble
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France
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Le Kremlin Bicetre Cedex
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France
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Lille Cedex
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France
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Montpellier Cedex 05
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France
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Nantes Cedex 01
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France
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Nice Cedex 1
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France
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Saint-Etienne
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France
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Toulouse Cedex 9
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France
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Vandoeuvre les Nancy Cedex
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Halle
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Germany
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Hann
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Germany
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Koln
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Germany
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Munchen
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Germany
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Regensburg
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Greece
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Athens
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Greece
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Thessaloniki
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Hungary
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Budapest
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Ireland
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Dublin
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Italy
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Bari
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Italy
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Milano
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Italy
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Padova
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Italy
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Palermo
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Italy
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Pisa
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Italy
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Siena
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Italy
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Treviso
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Mexico
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Cuernavaca Morelos
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Mexico
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Mexico D.F.
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Netherlands
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Maastricht
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Netherlands
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Utrecht
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Norway
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Oslo
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Poland
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Bydgoszcz
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Poland
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Szczecin
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Pretoria
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Spain
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Badalona Barcelona
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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La Coruna
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Santander
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Spain
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Sevilla
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Sweden
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Goteborg
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Sweden
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Uppsala
Country [66] 0 0
Switzerland
State/province [66] 0 0
Zurich
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United Kingdom
State/province [67] 0 0
Belfast
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Birmingham
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Coventry
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Glasgow
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.
Trial website
https://clinicaltrials.gov/study/NCT00189839
Trial related presentations / publications
Kramer BK, Albano L, Banas B, Charpentier B, Backman L, Tedesco-Silva H Jr, Lehner F, Mondragon-Ramirez GA, Glyda M, Cassuto-Viguier E, Viklicky O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.
Public notes

Contacts
Principal investigator
Name 0 0
B Krämer
Address 0 0
Klinikum der Universität Regensburg
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00189839