Status:
COMPLETED
Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Bronchiolitis Obliterans
Immunosuppression
Eligibility:
All Genders
18-66 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare efficacy and safety of two different immunosuppressive regimens for prevention of bronchiolitis obliterans syndrome (BOS) (chronic lung allograft rejection)after...
Detailed Description
Lung transplantation has become a viable treatment option for selected patients with end stage lung disease and leads to prolonged survival and improved quality of life. However, despite improvements ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT01429844
Start Date
January 1 2001
End Date
August 1 2010
Last Update
September 7 2011
Active Locations (14)
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1
St. Vincent's Hospital
Sydney, Australia, NSW 2010
2
Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
3
Hospital Erasme
Brussels, Belgium, 1070
4
Universitaire Ziekenhuizen
Leuven, Belgium, 3000