Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

Sponsor

Hannover Medical School (Other)

Overall Status

Completed

CT.gov ID

NCT00402532

Collaborator

Novartis Pharmaceuticals (Industry)

190

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Transplantation	Drug: Everolimus Drug: Mycophenolatmofetil	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

190 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

Study Start Date :

Mar 1, 2005

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Everolimus	Drug: Everolimus Initial dosage 2 x 0.75 mg/d Other Names: Certican
Active Comparator: Mycophenolatmofetil	Drug: Mycophenolatmofetil Initial dosage 2 x 500 mg/d intravenous Other Names: Cellcept

Arm

Intervention/Treatment

Active Comparator: Everolimus

Drug: Everolimus

Initial dosage 2 x 0.75 mg/d

Other Names:

Certican

Active Comparator: Mycophenolatmofetil

Drug: Mycophenolatmofetil

Initial dosage 2 x 500 mg/d intravenous

Other Names:

Cellcept

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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