Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hannover Medical School
• Collaborator: Novartis Pharmaceuticals
• Treatments: Everolimus; Immunosuppressive Agents; Sirolimus

Criteria

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