A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation
Launched by ASTELLAS PHARMA INC · Sep 13, 2005
Trial Information
Current as of May 18, 2025
Completed
Keywords
ClinConnect Summary
A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen.
Gender
ALL
Eligibility criteria
- 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).
- 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.
About Astellas Pharma Inc
Astellas Pharma Inc. is a global pharmaceutical company dedicated to improving the health of patients through innovative research and development. With a strong focus on urology, oncology, immunology, and neuroscience, Astellas is committed to advancing medical science and delivering transformative therapies. The company operates with a patient-centric approach, striving to address unmet medical needs while adhering to the highest standards of ethics and compliance in clinical trials. Astellas leverages cutting-edge technology and collaborates with healthcare professionals and institutions worldwide to bring forward new treatment options that enhance the quality of life for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Innsbruck, , Austria
Regensburg, , Germany
Cordoba, , Spain
Pretoria, , South Africa
Madrid, , Spain
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Oslo, , Norway
Nice Cedex 1, , France
Vandoeuvre Les Nancy Cedex, , France
Pisa, , Italy
Durban, , South Africa
Halifax, Nova Scotia, Canada
Lille Cedex, , France
Buenos Aires, , Argentina
Dublin, , Ireland
Melbourne, , Australia
Leuven, , Belgium
Belfast, , United Kingdom
Glasgow, , United Kingdom
Santander, , Spain
Manchester, , United Kingdom
Sydney, , Australia
Bruxelles, , Belgium
Essen, , Germany
Birmingham, , United Kingdom
Szczecin, , Poland
Barcelona, , Spain
Padova, , Italy
Santa Fe, , Argentina
Halle, , Germany
Palermo, , Italy
Utrecht, , Netherlands
Cape Town, , South Africa
Sevilla, , Spain
Grenoble, , France
Athens, , Greece
Budapest, , Hungary
Bochum, , Germany
Erlangen, , Germany
Milano, , Italy
Mexico D.F., , Mexico
Goteborg, , Sweden
Uppsala, , Sweden
Porto Alegre, , Brazil
Creteil, , France
Frankfurt, , Germany
Helsinki, , Finland
Praha 4, , Czech Republic
Westmead, , Australia
Koln, , Germany
Bari, , Italy
Thessaloniki, , Greece
Siena, , Italy
Berlin, , Germany
Munchen, , Germany
Le Kremlin Bicetre Cedex, , France
Montpellier Cedex 05, , France
Maastricht, , Netherlands
Bydgoszcz, , Poland
Zurich, , Switzerland
Toulouse Cedex 9, , France
Woudville South, , Australia
Campinas Sp, , Brazil
Rio De Janeiro Rj, , Brazil
San Paulo Sp, , Brazil
Nantes Cedex 01, , France
Saint Etienne, , France
Hann, , Germany
Treviso, , Italy
Cuernavaca Morelos, , Mexico
Badalona Barcelona, , Spain
La Coruna, , Spain
Malaga, , Spain
Coventry, , United Kingdom
Patients applied
Trial Officials
B Krämer
Principal Investigator
Klinikum der Universität Regensburg
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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