Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation (EAILTX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Hermann Reichenspurner, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01429844
First received: September 5, 2011
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Bronchiolitis Obliterans
Immunosuppression
Drug: Tacrolimus
Drug: Cyclosporine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Incidence of bronchiolitis obliterans syndrome [ Time Frame: 3 years post transplant ] [ Designated as safety issue: No ]
    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:
  • Acute allograft rejection [ Time Frame: 3 years post transplant ] [ Designated as safety issue: No ]
    One- and 3-year rates of acute allograft rejection determined by clinical criteria or transbronchial lung biopsy.

  • Patient and graft survival [ Time Frame: 3 years post transplant ] [ Designated as safety issue: No ]
    Patient and graft survival at one and three years

  • Incidence and spectrum of infections [ Time Frame: 3 years post transplant ] [ Designated as safety issue: Yes ]
    Incidence and spectrum (viral, bacterial, fungal)of infections after transplantation

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

  • Treatment failure [ Time Frame: 3 years post transplant ] [ Designated as safety issue: No ]
    Treatment failure defined as drug discontinuation (e.g. conversion to a different immunosuppression regimen)


Enrollment: 274
Study Start Date: January 2001
Study Completion Date: August 2010
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429844

Locations
Australia
St. Vincent's Hospital
Sydney, Australia, NSW 2010
Austria
Allgemeines Krankenhaus Wien
Wien, Austria, 1090
Belgium
Hospital Erasme
Bruxelles, Belgium, 1070
Universitaire Ziekenhuizen
Leuven, Belgium, 3000
Germany
Universitätsklinikum Essen
Essen, Germany, 45147
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Universitätsklinikum Jena
Jena, Germany, 07740
Universitätsklinikum Kiel
Kiel, Germany, 24105
Spain
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
Switzerland
Centre hospitalier universitaire vaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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
  More Information

Additional Information:
Publications:

Responsible Party: Prof. Dr. Hermann Reichenspurner, Prof. Dr. med. Hermann Reichenspurner, PhD, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01429844     History of Changes
Other Study ID Numbers: EAILTx Tac vs. CsA in LuTx
Study First Received: September 5, 2011
Last Updated: September 6, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Calcineurin inhibitors
Bronchiolitis obliterans
Lung transplantation
Cyclosporine
Tacrolimus
Mycophenolate
Steroids
Chronic rejection
Acute rejection
Obliterative bronchiolitis

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014