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ISRCTN
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ISRCTN58758525
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ClinicalTrials.gov identifier
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Public title
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A Phase II Randomised Study of the Addition of Methotrexate 0.05 mg/kg 12 hourly for 8 doses to the Current Immunosuppressant Regimen for the Prevention of Liver Allograft Rejection.
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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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N0265006492
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Study hypothesis
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Two thirds of patients receiving an orthotopic liver allograft suffer acute graft rejection episodes within the first few weeks post transplant despite current immunosuppressant therapy. This deficiency in current therapy necessitates the administration of high dose steroids in these patients, in a smaller proportion is associated with early graft loss and may in other patients be associated with graft loss from the subsequent development of a chronic graft rejection process. The aim of the proposed trial is to assess the safety and efficacy of the addition to current immunosuppressant therapy of 0.05mg/kg methotrexate given 12 hourly for four days from 24 hours post transplant. The rationale for this therapeutic strategy lies in its common application to the prevention of graft versus host disease after allogeneic bone marrow transplantation; the efficacy of methotrexate in treating established rejection episodes in cardiac allografts; the efficacy of methotrexate in preventing organ allograft rejection in experimental animals.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Not Applicable: Liver allograf
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2004
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Anticipated end date
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01/01/2007
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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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60
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Interventions
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60 consecutive adult patients who have previously consented to participate in the trial will be randomised to one of two treatment groups at the time of liver transplantation. The treatment groups are 'standard' or 'standard / methotrexate' immunosuppressant regimen. The two treatment groups will be assessed for:
1. Adverse effects attributable to their immunosuppressant therapy
2. Incidence and severity of early graft rejection episodes 3. Use of additional immunosuppressant drugs, particularly corticosteroids
4. Incidence of late acute graft rejection episodes and incidence of chronic graft rejection.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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University Hospital Birmingham NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Prof
P
McMaster
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Address
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Liver Surgery
Queen Elizabeth Hospital
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City/town
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Birmingham
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Zip/Postcode
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B15 2TH
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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11/06/2008
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Date ISRCTN assigned
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30/09/2005
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