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Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation (EAILTX)

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ClinicalTrials.gov Identifier: NCT01429844
Recruitment Status : Completed
First Posted : September 7, 2011
Last Update Posted : September 7, 2011
Information provided by (Responsible Party):
Prof. Dr. Hermann Reichenspurner, Universitätsklinikum Hamburg-Eppendorf

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 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

Condition or disease Intervention/treatment Phase
Bronchiolitis Obliterans Immunosuppression Drug: Tacrolimus Drug: Cyclosporine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : January 2001
Actual Primary Completion Date : October 2007
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Active Comparator: Tacrolimus
Tacrolimus in combination with mycophenolate mofetil and steroids for denovo immunosuppression after lung transplantation
Drug: Tacrolimus
Tacrolimus therapy was started immediately after transplantation with a continuous intravenous infusion of 0.01-0.03 mg/kg/d. After extubation, the mode of delivery was switched to oral administration (b.i.d.) with doses of 0.05-0.3 mg/kg/d. Tacrolimus doses were adjusted to trough levels. Target C0 (trough) levels were 10-15 ng/ml for the first 3 months after transplantation and 8-12 ng/ml thereafter with dose adjustments according to patient outcome.
Other Names:
  • FK 506
  • Prograf

Active Comparator: Cyclosporine
Cyclopsorine in combination with mycophenolate mofetil and steroids for denovo immunosuppression after lung transplantation
Drug: Cyclosporine
Cyclosporine therapy was started immediately after transplantation with a continuous intravenous infusion of 1-3 mg/kg/d. After extubation the mode of delivery was switched to oral administration (b.i.d. or t.i.d.) with doses of 4-18 mg/kg/d. Cyclosporine doses were adjusted to C0 or C2 levels according to local practice. Target trough levels were 200 - 300 ng/ml for the first 3 months after transplantation and 150 - 200 ng/ml thereafter.
Other Names:
  • CyA
  • CsA
  • Cyclosporine A
  • Sandimmune

Primary Outcome Measures :
  1. Incidence of bronchiolitis obliterans syndrome [ Time Frame: 3 years post transplant ]
    The incidence of patients with bronchiolitis obliterans syndrome (BOS), defined as a sustained fall (for >1 month) in maximum FEV1 of 20% or more (compared to baseline) over three years post transplant.

Secondary Outcome Measures :
  1. Acute allograft rejection [ Time Frame: 3 years post transplant ]
    One- and 3-year rates of acute allograft rejection determined by clinical criteria or transbronchial lung biopsy.

  2. Patient and graft survival [ Time Frame: 3 years post transplant ]
    Patient and graft survival at one and three years

  3. Incidence and spectrum of infections [ Time Frame: 3 years post transplant ]
    Incidence and spectrum (viral, bacterial, fungal)of infections after transplantation

  4. Renal failure [ Time Frame: 3 years post transplant ]
    Post operative onset of renal dysfunction (defined as a persistent increase in serum creatinine of > 2mg/dl) or dialysis dependency

  5. Treatment failure [ Time Frame: 3 years post transplant ]
    Treatment failure defined as drug discontinuation (e.g. conversion to a different immunosuppression regimen)

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429844

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St. Vincent's Hospital
Sydney, Australia, NSW 2010
Allgemeines Krankenhaus Wien
Wien, Austria, 1090
Hospital Erasme
Bruxelles, Belgium, 1070
Universitaire Ziekenhuizen
Leuven, Belgium, 3000
Universitätsklinikum Essen
Essen, Germany, 45147
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Universitätsklinikum Jena
Jena, Germany, 07740
Universitätsklinikum Kiel
Kiel, Germany, 24105
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Reina Sofia
Cordoba, Spain, 14004
Hospital Juan Canalejo
La Coruna, Spain, 15006
Clínica Puerta de Hierro
Madrid, Spain, 28035
Hospital Marques de Valdecilla
Santander, Spain, 39008
Centre hospitalier universitaire vaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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Principal Investigator: Hermann Reichenspurner, MD, PhD Universitätsklinikum Hamburg Eppendorf, Hamburg, Germany
Study Chair: Allan Glanville, MD, PhD St Vincent's Hospital - Sydney, Australia
Study Chair: Hendrik Treede, MD Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany
Additional Information:

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Responsible Party: Prof. Dr. Hermann Reichenspurner, Prof. Dr. med. Hermann Reichenspurner, PhD, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01429844    
Other Study ID Numbers: EAILTx Tac vs. CsA in LuTx
First Posted: September 7, 2011    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011
Keywords provided by Prof. Dr. Hermann Reichenspurner, Universitätsklinikum Hamburg-Eppendorf:
Calcineurin inhibitors
Bronchiolitis obliterans
Lung transplantation
Chronic rejection
Acute rejection
Obliterative bronchiolitis
Additional relevant MeSH terms:
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Bronchiolitis Obliterans
Respiratory Tract Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents