A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection
OSAKA
A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study)
2 other identifiers
interventional
1,252
22 countries
110
Brief Summary
To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2008
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2008
CompletedFirst Submitted
Initial submission to the registry
July 16, 2008
CompletedFirst Posted
Study publicly available on registry
July 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2010
CompletedNovember 1, 2024
October 1, 2024
1.8 years
July 16, 2008
October 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy failure rate
24 weeks
Secondary Outcomes (1)
Renal Function, acute rejection, Biopsy confirmed acute rejection
24 weeks
Study Arms (4)
Prograf + MMF + Steroids
ACTIVE COMPARATORoral
Advagraf (dose 1) + MMF + steroids
ACTIVE COMPARATORoral
Advagraf (dose 2) + MMF + steroids
ACTIVE COMPARATORoral
Advagraf + MMF + Basilixmab + steroids
ACTIVE COMPARATORoral
Interventions
oral
oral
oral
Eligibility Criteria
You may qualify if:
- End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
- 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
You may not qualify if:
- Receiving or having previously received an organ transplant other than a kidney
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (110)
Unknown Facility
Buenos Aires, C1425FAB, Argentina
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Córdoba, X5016KEH, Argentina
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Innsbruck, A-6020, Austria
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Linz, A-4010, Austria
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Vienna, A-1090, Austria
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Brno, 65691, Czechia
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Hradec Kravlove, 50005, Czechia
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Ostrava, 70852, Czechia
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Prague, 14021, Czechia
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Angers, 49033, France
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Bordeaux, 33076, France
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Brest, 29609, France
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Créteil, 94010, France
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La Tronche, 38700, France
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Le Kremlin-Bicêtre, 94275, France
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Limoges, 87042, France
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Lyon, 69437, France
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Nantes, 44035, France
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Nice, 06002, France
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Paris, 75743, France
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Paris, 75908, France
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Paris, 75970, France
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Rennes, 35033, France
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Saint-Etienne, 42055, France
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Strasbourg, 67091, France
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Suresnes, 92151, France
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Toulouse, 31054, France
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Tours, 37044, France
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Vandœuvre-lès-Nancy, 54511, France
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Aachen, 52074, Germany
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Berlin, 13353, Germany
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Essen, 45147, Germany
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Frankfurt, 60590, Germany
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Freiburg I. Br, 79106, Germany
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Halle, 06120, Germany
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Hamburg, 20251, Germany
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Hanover, 30625, Germany
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Jena, 07747, Germany
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Kaiserslautern, 67655, Germany
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Kiel, 24105, Germany
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Leipzig, 04103, Germany
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München, 81675, Germany
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Münster, 48149, Germany
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Regensburg, 93042, Germany
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Rostock, 18057, Germany
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Tübingen, 72076, Germany
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Athens, 11527, Greece
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Thessaloniki, 54642, Greece
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Budapest, 1082, Hungary
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Szeged, 6720, Hungary
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Dublin, Ireland
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Ancona, 60020, Italy
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Bologna, 40138, Italy
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Milan, 20162, Italy
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Padua, 35128, Italy
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Roma, 00144, Italy
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Siena, 53100, Italy
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Treviso, 31100, Italy
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Maastricht, 6202 AZ, Netherlands
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Oslo, NO-0027, Norway
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Bialystok, 15-540, Poland
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Gdansk, 80-211, Poland
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Lublin, 20-090, Poland
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Poznan, 60-479, Poland
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Warsaw, 022-006, Poland
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Wroclaw, 50-419, Poland
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Lisbon, 1069-639, Portugal
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Porto, 4099-001, Portugal
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Bucharest, 022328, Romania
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Cluj-Napoca, 400006, Romania
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Moscow, 123182, Russia
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Moscow, 129090, Russia
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Omsk, 644112, Russia
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Saint Petersburg, 197110, Russia
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Volgograd, 404120, Russia
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Banska Bysterica, 975 17, Slovakia
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Košice, 040 11, Slovakia
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Cape Town, 7925, South Africa
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Johannesburg, 2193, South Africa
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A Coruña, 15006, Spain
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Albacete, 02006, Spain
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Alicante, 03010, Spain
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Barakaldo-Vizcaya, 48903, Spain
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Barcelona, 08035, Spain
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Barcelona, 08907, Spain
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Cadiz, 11009, Spain
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Granada, 18012, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Madrid, 28046, Spain
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Murcia, 30120, Spain
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Oviedo, 33006, Spain
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Palma de Mallorca, 07014, Spain
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Pamplona, 31080, Spain
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Salamanca, 37007, Spain
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Seville, 41013, Spain
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Valencia, 46009, Spain
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Valencia, 46017, Spain
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Zaragoza, 50009, Spain
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Stockholm, S-14186, Sweden
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Uppsala, S-75185, Sweden
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Zurich, 8091, Switzerland
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Birmingham, B15 2TH, United Kingdom
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Glasgow, G11 6NT, United Kingdom
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Leicester, LE54PW, United Kingdom
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Manchester, M13 9WL, United Kingdom
Related Publications (2)
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.
PMID: 23982340BACKGROUNDKramer 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: 29149958DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Central Contact
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2008
First Posted
July 17, 2008
Study Start
May 14, 2008
Primary Completion
March 2, 2010
Study Completion
March 2, 2010
Last Updated
November 1, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.