Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: 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 driven

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Treatments: 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