Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

Lung Transplantation Clinical Trial

Official title:

Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402532
• Other study ID #: Ever-Lung-DE01/RAD-LungDE01
• Status: Completed
• Phase: Phase 3
• First received: November 20, 2006
• Last updated: December 7, 2011
• Start date: March 2005
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Drug:
• Everolimus
Initial dosage 2 x 0.75 mg/d
• Mycophenolatmofetil
Initial dosage 2 x 500 mg/d intravenous

Locations

Country	Name	City	State
Germany	Hannover Medical School, Division of Thoracic and Cardiovascular Surgery	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation		2 years	No
Secondary	Incidence and severity of Nephrotoxicity within 2 years of transplantation		2 years	No
Secondary	Incidence and severity of opportunistic infections within 2 years of transplantation		2 years	No