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Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

This study is currently recruiting participants.
Verified by Hannover Medical School, July 2007

Sponsors and Collaborators: Hannover Medical School
Novartis
Information provided by: Hannover Medical School
ClinicalTrials.gov Identifier: NCT00402532
  Purpose

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
Phase III

MedlinePlus related topics:   Lung Transplantation   

ChemIDplus related topics:   Everolimus   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Incidence and Severity of Bronchiolitis obliterans syndrome within 2 years from Transplantation
  • Mortality within 2 years of Transplantation
  • Need for Change of Immunosuppressive Medication within 2 years of Transplantation

Secondary Outcome Measures:
  • Incidence and severity of Nephrotoxicity within 2 years of transplantation
  • Incidence and severity of opportunistic infections within 2 years of transplantation

Estimated Enrollment:   180
Study Start Date:   March 2005
Estimated Study Completion Date:   December 2011

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402532

Contacts
Contact: Martin Strueber, Dr.     +49 511 532 3435     Strueber.Martin@mh-hannover.de    
Contact: Petra Oppelt     +49 511 532 6311     Oppelt.Petra@mh-hannover.de    

Locations
Germany
Hannover Medical School, Division of Thoracic and Cardiovascular Surgery     Recruiting
      Hannover, Germany, 30625
      Contact: Petra Oppelt     +49 511 532 6311     Oppelt.Petra@mh-hannover.de    
      Principal Investigator: Martin Strueber, Dr.            

Sponsors and Collaborators
Hannover Medical School
Novartis

Investigators
Principal Investigator:     Martin Strueber, Dr.     Hannover Medical School    
  More Information


Study ID Numbers:   Ever-Lung-DE01/RAD-LungDE01
First Received:   November 20, 2006
Last Updated:   July 31, 2007
ClinicalTrials.gov Identifier:   NCT00402532
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
Lung Transplantation  
Immunosuppression  
Mortality  
Graft rejection  
Bronchiolitis obliterans
Opportunistic infections
Nephrotoxicity

Study placed in the following topic categories:
Everolimus
Opportunistic Infections
Bronchiolitis
Bronchiolitis Obliterans

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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