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ISRCTN
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ISRCTN78828338
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ClinicalTrials.gov identifier
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Public title
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Pre-treatment of deceased organ donors with methylprednisolone versus placebo for the prevention of post-ischemic acute renal transplant failure
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Scientific title
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Acronym
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N/A
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Serial number at source
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P-18325
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Study hypothesis
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Deceased organ donors exhibit a severe systemic inflammatory response caused by the brain death syndrome. This leads to an activation of inflammatory regulators in the donor kidney, associated with increased risk for subsequent development of post-ischemic acute renal transplant failure (ARTF) in the recipient. ARTF is the main risk factor for shortened allograft survival. Pre-treatment of deceased organ donors with corticosteroids before organ retrieval may modify the genome-wide gene expression in the donor kidney and thus reduce the incidence and duration of post-ischemic ARTF after engraftment.
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Lay summary
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Ethics approval
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Approved by the Ethics Committee of the Medical University Vienna on 14/03/2005, reference number: 067/2005
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Study design
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Randomised placebo-controlled study
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Countries of recruitment
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Austria
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Disease/condition/study domain
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Pre-treatment of deceased organ donors
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Participants - inclusion criteria
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Deceased kidney donors
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Participants - exclusion criteria
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Non-heart beating organ donors
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Anticipated start date
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20/03/2006
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Anticipated end date
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20/09/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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200 deceased organ donors
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Interventions
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The deceased organ donor will be randomized to receive 1000 mg of methylprednisolone or placebo three to six hours before organ retrieval. Donor kidney biopsies will be obtained before engraftment and genome-wide gene expression analysis will be performed using complementary deoxyribonucleic acid (cDNA) microarrays.
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Primary outcome measure(s)
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Incidence and duration of post-ischemic acute renal transplant failure in the transplant recipient
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Secondary outcome measure(s)
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Genome-wide gene expression analysis of transplant kidney wedge biopsies
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Sources of funding
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Austrian Science Funds (grant P-18325)
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Trial website
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http://www.meduniwien.ac.at/nephrogene
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20713790
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Contact name
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Prof
Rainer
Oberbauer
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Address
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Vienna Medical University
Waehringer Gürtel 18-20
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City/town
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Vienna
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Zip/Postcode
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1090
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Country
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Austria
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Tel
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+43 (0)140 400 4358
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Fax
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+43 (0)140 400 4452
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Email
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rainer.oberbauer@meduniwien.ac.at
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Sponsor
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Austrian Science Fund
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Address
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Weyringergasse 35
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City/town
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Vienna
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Zip/Postcode
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1040
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Country
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Austria
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Tel
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+43 (0)1 505 67 40
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Fax
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+43 (0)1 505 67 39
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Email
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office@fwf.ac.at
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Sponsor website:
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http://www.fwf.ac.at
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Date applied
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14/03/2006
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Last edited
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04/11/2010
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Date ISRCTN assigned
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12/04/2006
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