Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Martin Strueber, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00402532
First received: November 20, 2006
Last updated: December 7, 2011
Last verified: December 2011
  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
Drug: Mycophenolatmofetil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and severity of Nephrotoxicity within 2 years of transplantation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Incidence and severity of opportunistic infections within 2 years of transplantation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Martin Strueber, Martin Strueber, MD, Hannover Medical School
ClinicalTrials.gov 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
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

Additional relevant MeSH terms:
Immunosuppressive Agents
Everolimus
Sirolimus
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 27, 2014