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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01429844 |
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Date of registration:
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05/09/2011 |
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Primary sponsor: |
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Public title:
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Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation
EAILTX |
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Scientific title:
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Randomized, Open-label, Multi-Center Study Comparing Tacrolimus With Cyclosporin, Both Arms in Combination With Mycophenolate Mofetil and Corticosteroids for Prevention of Bronchiolitis Obliterans Syndrome in Lung Transplant Patients |
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Date of first enrolment:
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January 2001 |
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Target sample size:
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274 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01429844 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Australia
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Austria
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Belgium
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Germany
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Spain
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Switzerland
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Contacts
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Name:
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Allan Glanville, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Vincent's Hospital, Sydney, Australia |
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Name:
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Hermann Reichenspurner, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitätsklinikum Hamburg Eppendorf, Hamburg, Germany |
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Name:
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Hendrik Treede, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- male or female recipients of a first heart-lung
- bilateral or single lung allograft suitable to receive triple immunosuppressive
therapy with tacrolimus or cyclosporine, MMF and corticosteroids per standard
guidelines
- Age range = 18-66 years
- Able to understand the purposes and risks of the study
- Female patients of child bearing age agreeing to maintain effective birth control
practice during the follow-up period
Exclusion Criteria:
- need for immunosuppressive regimen other than study medication or received additional
organ transplantations
- Pregnant women, nursing mothers or women unwilling to use adequate contraception
- Serologic evidence of human immunodeficiency virus, hepatitis B surface antigen or
hepatitis C virus antibodies
- Panresistant infections with Burkholderia cepacia or mycobacteria during the last 12
months preceding lung transplantation
- Patients with renal insufficiency (creatinine clearance < 40 ml/min
- Patients in need of invasive ventilator devices or extracorporeal membrane
oxygenation
Age minimum:
18 Years
Age maximum:
66 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bronchiolitis Obliterans
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Immunosuppression
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Intervention(s)
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Drug: Cyclosporine
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Drug: Tacrolimus
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Primary Outcome(s)
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Incidence of bronchiolitis obliterans syndrome
[Time Frame: 3 years post transplant]
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Secondary Outcome(s)
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Acute allograft rejection
[Time Frame: 3 years post transplant]
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Incidence and spectrum of infections
[Time Frame: 3 years post transplant]
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Patient and graft survival
[Time Frame: 3 years post transplant]
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Renal failure
[Time Frame: 3 years post transplant]
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Treatment failure
[Time Frame: 3 years post transplant]
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Secondary ID(s)
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EAILTx Tac vs. CsA in LuTx
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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