Lung Transplantation
Conditions
Keywords
Lung Transplantation, Immunosuppression, Mortality, Graft rejection, Bronchiolitis obliterans, Opportunistic infections, Nephrotoxicity
Brief summary
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.
Interventions
DRUGEverolimus
Initial dosage 2 x 0.75 mg/d
DRUGMycophenolatmofetil
Initial dosage 2 x 500 mg/d intravenous
Sponsors
Novartis Pharmaceuticals
Hannover Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Germany
Outcome results
None listed