Status:
COMPLETED
Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Lung Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00402532
Start Date
March 1 2005
End Date
December 1 2011
Last Update
December 8 2011
Active Locations (1)
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1
Hannover Medical School, Division of Thoracic and Cardiovascular Surgery
Hanover, Germany, 30625