Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Everolimus is effective in the treatment and prevention of chronic graft dysfunction and chronic graft rejection after lung transplantation.

Official Title
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Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

Conditions
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Lung Transplantation

Intervention / Treatment
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* Drug: Everolimus
* Drug: Mycophenolatmofetil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recipient of Single or Bilateral Lung Transplantation Informed consent Recipients who are able to receive Everolimus at week 3 after Lung Transplantation women of childbearing potential must have a negative pregnancy test within 48 hours of enrolment women of childbearing potential must use appropriate contraceptive method at enrolment, during the study and up to 8 weeks after the end of the study donor must not have relevant pulmonary diseases donor must have oxygen partial pressure higher than 300 mmHg at FiO 1.0 and positive end-expiratory pressure of 5 cm H2O. Exclusion Criteria: systemic infection of the donor donor: signs or symptoms of aspiration donor: severe pulmonary injury or contusion donor: malignant neoplasm of the lung donor: HIV positive recipients who receive immunosuppressive agents not used in this protocol recipients who participated within 30 days before study start or are currently participating in another investigational drug trial HIV positive recipient systemic infection of the recipient recipients of combined/ multiple transplantations pregnancy of the recipient recipients with signs/ Symptoms of impaired wound healing of the pulmonary anastomoses recipients who are still on artificial respiration or who are not able to swallow tablets at week 3 after transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Everolimus<br> | Drug: Everolimus<br>* Initial dosage 2 x 0.75 mg/d<br>* Other names: Certican;|
| Active Comparator: Mycophenolatmofetil<br> | Drug: Mycophenolatmofetil<br>* Initial dosage 2 x 500 mg/d intravenous<br>* Other names: Cellcept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of Nephrotoxicity within 2 years of transplantation |  | 2 years | 
| Incidence and severity of opportunistic infections within 2 years of transplantation |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Transplantation, Immunosuppression, Mortality, Graft rejection, Bronchiolitis obliterans, Opportunistic infections, Nephrotoxicity