Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

December 7, 2011 updated by: Martin Strueber, Hannover Medical School
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Hannover Medical School, Division of Thoracic and Cardiovascular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Everolimus
Drug: Everolimus
Initial dosage 2 x 0.75 mg/d
Other Names:
  • Certican
ACTIVE_COMPARATOR: Mycophenolatmofetil
Drug: Mycophenolatmofetil
Initial dosage 2 x 500 mg/d intravenous
Other Names:
  • Cellcept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of Nephrotoxicity within 2 years of transplantation
Time Frame: 2 years
2 years
Incidence and severity of opportunistic infections within 2 years of transplantation
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Collaborators

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 20, 2006

First Posted (ESTIMATE)

November 22, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2011

Last Update Submitted That Met QC Criteria

December 7, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ever-Lung-DE01/RAD-LungDE01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Transplantation

Clinical Trials on Everolimus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe