A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection
NCT ID: NCT00717470
Last Updated: 2024-11-01
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
PHASE4
1252 participants
INTERVENTIONAL
2008-05-14
2010-03-02
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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Prograf + MMF + Steroids
oral
Prograf®
oral
Mycophenolate Mofetil
oral
methylprednisolone / prednisone
oral
Advagraf (dose 1) + MMF + steroids
oral
Advagraf®
oral
Mycophenolate Mofetil
oral
methylprednisolone / prednisone
oral
Advagraf (dose 2) + MMF + steroids
oral
Advagraf®
oral
Mycophenolate Mofetil
oral
methylprednisolone / prednisone
oral
Advagraf + MMF + Basilixmab + steroids
oral
Advagraf®
oral
Mycophenolate Mofetil
oral
Simulect
oral
methylprednisolone / prednisone
oral
Interventions
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Prograf®
oral
Advagraf®
oral
Mycophenolate Mofetil
oral
Simulect
oral
methylprednisolone / prednisone
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type
* 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
Exclusion Criteria
* Cold ischemia time of the donor kidney \> 30 hours
* Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
* Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
* Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
* Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.
* Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
* Pregnant woman or breast-feeding mother
* Subject or donor known to be HIV positive
* Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
* Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully
* Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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Buenos Aires, , Argentina
Córdoba, , Argentina
Innsbruck, , Austria
Linz, , Austria
Vienna, , Austria
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Brno, , Czechia
Hradec Kravlove, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Angers, , France
Bordeaux, , France
Brest, , France
Créteil, , France
La Tronche, , France
Le Kremlin-Bicêtre, , France
Limoges, , France
Lyon, , France
Nantes, , France
Nice, , France
Paris, , France
Paris, , France
Paris, , France
Rennes, , France
Saint-Etienne, , France
Strasbourg, , France
Suresnes, , France
Toulouse, , France
Tours, , France
Vandœuvre-lès-Nancy, , France
Aachen, , Germany
Berlin, , Germany
Essen, , Germany
Frankfurt, , Germany
Freiburg I. Br, , Germany
Halle, , Germany
Hamburg, , Germany
Hanover, , Germany
Jena, , Germany
Kaiserslautern, , Germany
Kiel, , Germany
Leipzig, , Germany
München, , Germany
Münster, , Germany
Regensburg, , Germany
Rostock, , Germany
Tübingen, , Germany
Athens, , Greece
Thessaloniki, , Greece
Budapest, , Hungary
Szeged, , Hungary
Dublin, , Ireland
Ancona, , Italy
Bologna, , Italy
Milan, , Italy
Padua, , Italy
Roma, , Italy
Siena, , Italy
Treviso, , Italy
Maastricht, , Netherlands
Oslo, , Norway
Bialystok, , Poland
Gdansk, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Lisbon, , Portugal
Porto, , Portugal
Bucharest, , Romania
Cluj-Napoca, , Romania
Moscow, , Russia
Moscow, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Volgograd, , Russia
Banska Bysterica, , Slovakia
Košice, , Slovakia
Cape Town, , South Africa
Johannesburg, , South Africa
A Coruña, , Spain
Albacete, , Spain
Alicante, , Spain
Barakaldo-Vizcaya, , Spain
Barcelona, , Spain
Barcelona, , Spain
Cadiz, , Spain
Granada, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Murcia, , Spain
Oviedo, , Spain
Palma de Mallorca, , Spain
Pamplona, , Spain
Salamanca, , Spain
Seville, , Spain
Valencia, , Spain
Valencia, , Spain
Zaragoza, , Spain
Stockholm, , Sweden
Uppsala, , Sweden
Zurich, , Switzerland
Birmingham, , United Kingdom
Glasgow, , United Kingdom
Leicester, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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Albano L, Banas B, Klempnauer JL, Glyda M, Viklicky O, Kamar N; Optimising immunoSuppression After Kidney transplantation with ADVAGRAF Study Group. OSAKA trial: a randomized, controlled trial comparing tacrolimus QD and BD in kidney transplantation. Transplantation. 2013 Nov 27;96(10):897-903. doi: 10.1097/TP.0b013e3182a203bd.
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.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2007-005376-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PMR-EC-1210
Identifier Type: -
Identifier Source: org_study_id
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