NCT00402532

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

6.7 years

First QC Date

November 20, 2006

Last Update Submit

December 7, 2011

Conditions

Lung Transplantation

Keywords

Lung TransplantationImmunosuppressionMortalityGraft rejectionBronchiolitis obliteransOpportunistic infectionsNephrotoxicity

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation

    2 years

Secondary Outcomes (2)

  • Incidence and severity of Nephrotoxicity within 2 years of transplantation

    2 years

  • Incidence and severity of opportunistic infections within 2 years of transplantation

    2 years

Study Arms (2)

Everolimus

ACTIVE COMPARATOR
Drug: Everolimus

Mycophenolatmofetil

ACTIVE COMPARATOR
Drug: Mycophenolatmofetil

Interventions

EverolimusDRUG

Initial dosage 2 x 0.75 mg/d

Also known as: Certican
Everolimus
MycophenolatmofetilDRUG

Initial dosage 2 x 500 mg/d intravenous

Also known as: Cellcept
Mycophenolatmofetil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School, Division of Thoracic and Cardiovascular Surgery

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Bronchiolitis ObliteransOpportunistic Infections

Interventions

EverolimusMycophenolic Acid

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesInfections

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Martin Strueber, Dr.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Martin Strueber, MD

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 22, 2006

Study Start

March 1, 2005

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

December 8, 2011

Record last verified: 2011-12

Locations

DE(1)