Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects
CONCERTO
A Multicenter, Single-arm, Open, Conversion Study From a Cyclosporine (CyA) Based Immunosuppressive Regimen to a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Kidney Transplant Subjects (CONCERTO: Converting Cyclosporine to FK506E (MR4) in Renal Transplantation)
1 other identifier
interventional
346
13 countries
56
Brief Summary
Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2007
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 30, 2007
CompletedFirst Posted
Study publicly available on registry
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedJuly 18, 2014
July 1, 2014
2 years
May 30, 2007
July 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in creatinine clearance, calculated according to Cockcroft and Gault formula.
Week 24
Secondary Outcomes (2)
Change in creatinine clearance, calculated according to Cockcroft and Gault formula, between Baseline (Day 1) and week 24 (End of Study) overall
Week 24
Rating of subjects according to reason for conversion: Changes in mean lipid levels (total cholesterol)
Week 24
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Serum creatinine \< 200 µmol/l (\< 2.3 mg/dl) at enrollment.
- Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study.
- Capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent (signed Informed Consent has been obtained).
You may not qualify if:
- Previously received an organ transplant other than a kidney.
- Acute rejection episode within 12 weeks prior to enrollment, or an acute rejection episode within the 24 weeks prior to enrollment that required anti-lymphocyte antibody therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
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Innsbruck, Austria
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Linz, Austria
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Vienna, Austria
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Brussels, Belgium
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Edegem, Belgium
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Olomouc, Czechia
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Prague, Czechia
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Aarhus, Denmark
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Helsinki, Finland
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Bordeaux, France
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Brest, France
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Paris, France
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Pierre-Bénite, France
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Strasbourg, France
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Toulouse, France
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Tours, France
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Vandœuvre-lès-Nancy, France
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Berlin, Germany
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Cologne, Germany
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Essen, Germany
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Halle, Germany
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Hanover, Germany
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Heidelberg, Germany
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Leipzig, Germany
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Lübeck, Germany
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Munich, Germany
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Tübingen, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Bologna, Italy
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Cagliari, Italy
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Florence, Italy
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Genova, Italy
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L’Aquila, Italy
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Milan, Italy
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Modena, Italy
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Napoli, Italy
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Padua, Italy
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Treviso, Italy
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Udine, Italy
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Gdansk, Poland
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Lublin, Poland
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Poznan, Poland
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Warsaw, Poland
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Alicante, Spain
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Badajoz, Spain
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Barakaldo, Spain
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Madrid, Spain
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Oviedo, Spain
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Palma de Mallorca, Spain
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Salamanca, Spain
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Lund, Sweden
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Zurich, Switzerland
Related Publications (1)
Rostaing L, Sanchez-Fructuoso A, Franco A, Glyda M, Kuypers DR, Jaray J. Conversion to tacrolimus once-daily from ciclosporin in stable kidney transplant recipients: a multicenter study. Transpl Int. 2012 Apr;25(4):391-400. doi: 10.1111/j.1432-2277.2011.01409.x. Epub 2011 Dec 27.
PMID: 22211928DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2007
First Posted
June 1, 2007
Study Start
April 1, 2007
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
July 18, 2014
Record last verified: 2014-07