Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

Phase 3

Completed

• Conditions: Lung Transplantation
• Interventions: Drug: Everolimus; Drug: Mycophenolatmofetil

• Registration Number: NCT00402532
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2006-11-20
• Study First Submitted QC: 2006-11-20
• Study First Posted: 2006-11-22
• Primary Completion: 2011-11
• Status Verified: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everolimus	Everolimus	-
Mycophenolatmofetil	Mycophenolatmofetil	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hannover Medical School, Division of Thoracic and Cardiovascular Surgery; 🇩🇪 Hannover, Germany