Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

Hannover Medical School (MHH)

Status and phase

Completed

Phase 3

Conditions

Lung Transplantation

Treatments

Drug: Everolimus

Drug: Mycophenolatmofetil

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00402532

Ever-Lung-DE01/RAD-LungDE01

Details and patient eligibility

About

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.

Enrollment

190 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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