A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation
NCT ID: NCT00189839
Last Updated: 2014-07-09
Study Results
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Basic Information
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COMPLETED
PHASE3
699 participants
INTERVENTIONAL
2004-08-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
tacrolimus
Immunosuppression
2
tacrolimus
Immunosuppression
Interventions
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tacrolimus
Immunosuppression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma Europe BV
Principal Investigators
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B Krämer
Role: PRINCIPAL_INVESTIGATOR
Klinikum der Universität Regensburg
Locations
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Buenos Aires, , Argentina
Santa Fe, , Argentina
Melbourne, , Australia
Sydney, , Australia
Westmead, , Australia
Woudville South, , Australia
Innsbruck, , Austria
Brussels, , Belgium
Brussels, , Belgium
Leuven, , Belgium
Campinas - SP, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro - RJ, , Brazil
San Paulo - SP, , Brazil
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Prague, , Czechia
Helsinki, , Finland
Créteil, , France
Grenoble, , France
Le Kremlin-Bicêtre, , France
Lille, , France
Montpellier, , France
Nantes, , France
Nice, , France
Saint-Etienne, , France
Toulouse, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Bochum, , Germany
Cologne, , Germany
Erlangen, , Germany
Essen, , Germany
Frankfurt, , Germany
Halle, , Germany
Hann, , Germany
München, , Germany
Regensburg, , Germany
Athens, , Greece
Thessaloniki, , Greece
Budapest, , Hungary
Dublin, , Ireland
Bari, , Italy
Milan, , Italy
Padua, , Italy
Palermo, , Italy
Pisa, , Italy
Siena, , Italy
Treviso, , Italy
Cuernavaca Morelos, , Mexico
Mexico City, , Mexico
Maastricht, , Netherlands
Utrecht, , Netherlands
Oslo, , Norway
Bydgoszcz, , Poland
Szczecin, , Poland
Cape Town, , South Africa
Cape Town, , South Africa
Durban, , South Africa
Pretoria, , South Africa
A Coruña, , Spain
Badalona Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Madrid, , Spain
Málaga, , Spain
Santander, , Spain
Seville, , Spain
Gothenburg, , Sweden
Uppsala, , Sweden
Zurich, , Switzerland
Belfast, , United Kingdom
Birmingham, , United Kingdom
Coventry, , United Kingdom
Glasgow, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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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.
Other Identifiers
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FG-506E-12-03
Identifier Type: -
Identifier Source: org_study_id
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