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Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

NCT ID: NCT00402532

Last Updated: 2011-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Transplantation

Keywords

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Lung Transplantation Immunosuppression Mortality Graft rejection Bronchiolitis obliterans Opportunistic infections Nephrotoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Everolimus

Group Type ACTIVE_COMPARATOR

Everolimus

Intervention Type DRUG

Initial dosage 2 x 0.75 mg/d

Mycophenolatmofetil

Group Type ACTIVE_COMPARATOR

Mycophenolatmofetil

Intervention Type DRUG

Initial dosage 2 x 500 mg/d intravenous

Interventions

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Everolimus

Initial dosage 2 x 0.75 mg/d

Intervention Type DRUG

Mycophenolatmofetil

Initial dosage 2 x 500 mg/d intravenous

Intervention Type DRUG

Other Intervention Names

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Certican Cellcept

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Martin Strueber

Martin Strueber, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Strueber, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Hannover Medical School, Division of Thoracic and Cardiovascular Surgery

Hanover, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Ever-Lung-DE01/RAD-LungDE01

Identifier Type: -

Identifier Source: org_study_id