Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01429844
• Date of registration: 05/09/2011
• Prospective Registration: No
• Primary sponsor: Universitätsklinikum Hamburg-Eppendorf
• Public title: Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation EAILTX
• Scientific title: 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
• Date of first enrolment: January 2001
• Target sample size: 274
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01429844
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Germany, Spain, Switzerland

Contacts

• Name: Allan Glanville, MD, PhD
• Affiliation: St. Vincent's Hospital, Sydney, Australia

• Name: Hendrik Treede, MD
• Affiliation: Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

• Name: Hermann Reichenspurner, MD, PhD
• Affiliation: Universitätsklinikum Hamburg Eppendorf, Hamburg, Germany

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 66 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Immunosuppression

Bronchiolitis Obliterans

Intervention(s)

Drug: Cyclosporine

Drug: Tacrolimus

Primary Outcome(s)

Incidence of bronchiolitis obliterans syndrome [Time Frame: 3 years post transplant]

Secondary Outcome(s)

Incidence and spectrum of infections [Time Frame: 3 years post transplant]

Acute allograft rejection [Time Frame: 3 years post transplant]

Patient and graft survival [Time Frame: 3 years post transplant]

Renal failure [Time Frame: 3 years post transplant]

Treatment failure [Time Frame: 3 years post transplant]

Secondary ID(s)

EAILTx Tac vs. CsA in LuTx

Source(s) of Monetary Support

Please refer to primary and secondary sponsors