Overview
Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation
Status:
Completed
Completed
Trial end date:
2010-08-01
2010-08-01
Target enrollment:
0
0
Participant gender:
All
All
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 lung transplantation: tacrolimus versus cyclosporine, both in combination with mycophenolate mofetil and steroids. The study was powered to detect a 15% reduction in BOS in tacrolimus treated patients. Study design: open-label, randomized, comparative, multi-center, investigator drivenPhase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Universitätsklinikum Hamburg-EppendorfTreatments:
Cyclosporine
Cyclosporins
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Criteria
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