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Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

This study has been completed.
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Martin Strueber, Hannover Medical School Identifier:
First received: November 20, 2006
Last updated: December 7, 2011
Last verified: December 2011
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 Intervention Phase
Lung Transplantation
Drug: Everolimus
Drug: Mycophenolatmofetil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

Resource links provided by NLM:

Further study details as provided by Martin Strueber, Hannover Medical School:

Primary Outcome Measures:
  • 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:
  • Incidence and severity of Nephrotoxicity within 2 years of transplantation [ Time Frame: 2 years ]
  • Incidence and severity of opportunistic infections within 2 years of transplantation [ Time Frame: 2 years ]

Enrollment: 190
Study Start Date: March 2005
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Martin Strueber, Martin Strueber, MD, Hannover Medical School Identifier: NCT00402532     History of Changes
Other Study ID Numbers: Ever-Lung-DE01/RAD-LungDE01
Study First Received: November 20, 2006
Last Updated: December 7, 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 processed this record on May 25, 2017