Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects
NCT ID: NCT00481481
Last Updated: 2014-07-18
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
346 participants
INTERVENTIONAL
2007-04-30
2009-04-30
Brief Summary
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Detailed Description
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Twenty-four weeks of treatment on MR4-based immunosuppressive regimen is considered to be an appropriate study duration in order to assess the response in subjects suffering from one or more known cyclosporine side effects, hypertrichosis/hirsutism, gingival hyperplasia, hyperlipidemia, arterial hypertension.
Stable, adult kidney transplant recipients (≥ 12 months post transplant) who are currently treated with cyclosporine and who meet the Inclusion and Exclusion Criteria will be enrolled.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
tacrolimus
immunosuppression
Interventions
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tacrolimus
immunosuppression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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
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_DIRECTOR
Astellas Pharma GmbH
Locations
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Innsbruck, , Austria
Linz, , Austria
Vienna, , Austria
Brussels, , Belgium
Edegem, , Belgium
Leuven, , Belgium
Liège, , Belgium
Roeselare, , Belgium
Olomouc, , Czechia
Prague, , Czechia
Aarhus, , Denmark
Helsinki, , Finland
Bordeaux, , France
Brest, , France
Paris, , France
Pierre-Bénite, , France
Strasbourg, , France
Toulouse, , France
Tours, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Cologne, , Germany
Essen, , Germany
Halle, , Germany
Hanover, , Germany
Heidelberg, , Germany
Leipzig, , Germany
Lübeck, , Germany
Munich, , Germany
Tübingen, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Bologna, , Italy
Cagliari, , Italy
Florence, , Italy
Genova, , Italy
L’Aquila, , Italy
Milan, , Italy
Modena, , Italy
Napoli, , Italy
Padua, , Italy
Treviso, , Italy
Udine, , Italy
Gdansk, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Alicante, , Spain
Badajoz, , Spain
Barakaldo, , Spain
Madrid, , Spain
Oviedo, , Spain
Palma de Mallorca, , Spain
Salamanca, , Spain
Lund, , Sweden
Zurich, , Switzerland
Countries
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References
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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.
Other Identifiers
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PMR-EC-1209
Identifier Type: -
Identifier Source: org_study_id
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