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

Drug Information available for: 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
Study 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 January 14, 2009