To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.
NCT ID: NCT00296361
Last Updated: 2014-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
634 participants
INTERVENTIONAL
2004-10-31
2006-07-31
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
NONE
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
Exclusion Criteria
* Cold ischemia time greater than 30 hours
* Patient has significant liver disease
* Patient has severe hypercholesterolaemia
* Patient is allergic or intolerant to study medication
* Patient requires ongoing dosing with corticosteroids.
* Patient or donor is known to be HIV positive
* Patient with malignancy or history of malignancy
18 Years
60 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Physician
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Nedlands, , Australia
Perth, , Australia
Linz, , Austria
Linz, , Austria
Vienna, , Austria
Brussels, , Belgium
Brussels, , Belgium
Leuven, , Belgium
Olomouc, , Czechia
Ostrava, , Czechia
Amiens, , France
Brest, , France
Dijon, , France
Limoges, , France
Paris, , France
Paris, , France
Paris, , France
Toulouse, , France
Aachen, , Germany
Bochum, , Germany
Cologne, , Germany
Cologne, , Germany
Freiburg im Breisgau, , Germany
Halle, , Germany
Hamburg, , Germany
Hannoversch Münden, , Germany
Hanover, , Germany
Münster, , Germany
Regensburg, , Germany
Rostock, , Germany
Debrecen, , Hungary
Milan, , Italy
Napoli, , Italy
Rotterdam, , Netherlands
Gdansk, , Poland
Krakow, , Poland
Poznan, , Poland
Szczecin, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bucharest, , Romania
Alicante, , Spain
Badalona-Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Cadiz, , Spain
Córdoba, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Palma de Mallorca, , Spain
Santander, , Spain
Santiago de Compostela, , Spain
Valencia, , Spain
Valencia, , Spain
Valladolid, , Spain
Gothenburg, , Sweden
London, , United Kingdom
Nottingham, , United Kingdom
Countries
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Related Links
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Link to FDA Website
Other Identifiers
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FG-506-02-40
Identifier Type: -
Identifier Source: org_study_id
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