A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation

NCT00189839 | Completed Phase 3 DMC

• 1 other identifier: FG-506E-12-03
• Study Type: interventional
• Target: 699
• Locations: 22 countries
• Sites: 79

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.

Conditions

Kidney Transplantation

Keywords

Tacrolimus; Kidney transplantation; Transplantation, kidney; Renal Transplantation; Transplantation, renal

Outcome Measures

Primary Outcomes (1)

• Time to and incidence of biopsy-proven acute rejections

  12 months

Secondary Outcomes (1)

• Overall rate of acute rejections

  12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: tacrolimus

2

EXPERIMENTAL

Drug: tacrolimus

Interventions

tacrolimus DRUG

Immunosuppression

Also known as: FK506E, MR4

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (80)

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Buenos Aires, Argentina

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Santa Fe, Argentina

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Melbourne, Australia

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Sydney, Australia

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Westmead, Australia

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Woudville South, Australia

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Innsbruck, Austria

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Brussels, 1070, Belgium

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Brussels, 1200, Belgium

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Leuven, Belgium

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Campinas - SP, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro - RJ, Brazil

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San Paulo - SP, Brazil

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Prague, Czechia

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Helsinki, Finland

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Créteil, France

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Grenoble, France

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Le Kremlin-Bicêtre, France

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Lille, France

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Montpellier, France

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Nantes, France

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Nice, France

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Saint-Etienne, France

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Toulouse, France

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Vandœuvre-lès-Nancy, France

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Berlin, Germany

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Bochum, Germany

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Cologne, Germany

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Erlangen, Germany

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Essen, Germany

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Frankfurt, Germany

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Halle, Germany

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Hann, Germany

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München, Germany

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Regensburg, Germany

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Athens, Greece

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Thessaloniki, Greece

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Budapest, Hungary

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Dublin, Ireland

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Bari, Italy

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Milan, Italy

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Padua, Italy

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Palermo, Italy

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Pisa, Italy

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Siena, Italy

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Treviso, Italy

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Cuernavaca Morelos, Mexico

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Mexico City, Mexico

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Maastricht, Netherlands

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Utrecht, Netherlands

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Oslo, Norway

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Bydgoszcz, Poland

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Szczecin, Poland

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Cape Town, 7925, South Africa

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Cape Town, 8001, South Africa

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Durban, South Africa

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Pretoria, South Africa

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A Coruña, Spain

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Badalona Barcelona, Spain

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Barcelona, 08025, Spain

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Barcelona, 08035, Spain

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Barcelona, Spain

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Córdoba, Spain

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Madrid, 28034, Spain

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Málaga, Spain

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Santander, Spain

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Seville, Spain

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Gothenburg, Sweden

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Uppsala, Sweden

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Zurich, Switzerland

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Belfast, United Kingdom

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Birmingham, United Kingdom

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Coventry, United Kingdom

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Glasgow, United Kingdom

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Manchester, United Kingdom

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Related Publications (1)

• 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.

  PMID: 29149958 DERIVED

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• B Krämer

  Klinikum der Universität Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: August 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

ES (10); FI (1); AU (4); PL (2); ME (2); DE (10); IT (7); BE (3); CA (4); BR (4); FR (10); AR (2); GR (2); NL (2); IE (1); NO (1); HU (1); ZA (4); GB (5); SE (2); CH (1); CZ (1)