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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01429844




Registration number
NCT01429844
Ethics application status
Date submitted
5/09/2011
Date registered
7/09/2011
Date last updated
7/09/2011

Titles & IDs
Public title
Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation
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
Secondary ID [1] 0 0
EAILTx Tac vs. CsA in LuTx
Universal Trial Number (UTN)
Trial acronym
EAILTX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis Obliterans 0 0
Immunosuppression 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tacrolimus
Treatment: Drugs - Cyclosporine

Active comparator: Tacrolimus - Tacrolimus in combination with mycophenolate mofetil and steroids for denovo immunosuppression after lung transplantation

Active comparator: Cyclosporine - Cyclopsorine in combination with mycophenolate mofetil and steroids for denovo immunosuppression after lung transplantation


Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of bronchiolitis obliterans syndrome
Timepoint [1] 0 0
3 years post transplant
Secondary outcome [1] 0 0
Acute allograft rejection
Timepoint [1] 0 0
3 years post transplant
Secondary outcome [2] 0 0
Patient and graft survival
Timepoint [2] 0 0
3 years post transplant
Secondary outcome [3] 0 0
Incidence and spectrum of infections
Timepoint [3] 0 0
3 years post transplant
Secondary outcome [4] 0 0
Renal failure
Timepoint [4] 0 0
3 years post transplant
Secondary outcome [5] 0 0
Treatment failure
Timepoint [5] 0 0
3 years post transplant

Eligibility
Key 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
Minimum age
18 Years
Maximum age
66 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
274
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
NSW 2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Germany
State/province [4] 0 0
Essen
Country [5] 0 0
Germany
State/province [5] 0 0
Hamburg
Country [6] 0 0
Germany
State/province [6] 0 0
Jena
Country [7] 0 0
Germany
State/province [7] 0 0
Kiel
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Spain
State/province [9] 0 0
Cordoba
Country [10] 0 0
Spain
State/province [10] 0 0
La Coruna
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
Spain
State/province [12] 0 0
Santander
Country [13] 0 0
Switzerland
State/province [13] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Other
Name
Universitätsklinikum Hamburg-Eppendorf
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hermann Reichenspurner, MD, PhD
Address 0 0
Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01429844