Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00402532
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : December 8, 2011
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Martin Strueber, 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.

Condition or disease Intervention/treatment Phase
Lung Transplantation Drug: Everolimus Drug: Mycophenolatmofetil Phase 3

Study Type : Interventional  (Clinical Trial)
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 : March 2005
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Incidence and severity of Nephrotoxicity within 2 years of transplantation [ Time Frame: 2 years ]
  2. Incidence and severity of opportunistic infections within 2 years of transplantation [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00402532

Hannover Medical School, Division of Thoracic and Cardiovascular Surgery
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Novartis Pharmaceuticals
Principal Investigator: Martin Strueber, Dr. Hannover Medical School

Responsible Party: Martin Strueber, Martin Strueber, MD, Hannover Medical School Identifier: NCT00402532     History of Changes
Other Study ID Numbers: Ever-Lung-DE01/RAD-LungDE01
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011

Keywords provided by Martin Strueber, Hannover Medical School:
Lung Transplantation
Graft rejection
Bronchiolitis obliterans
Opportunistic infections

Additional relevant MeSH terms:
Immunosuppressive Agents
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents