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Immune Mechanisms of Rejection in Human Lung Allografts

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00861900
Collaborator
National Institutes of Health (NIH) (NIH)
778
Enrollment
234
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The investigators have obtained compelling evidence that the development of anti-human leukocyte antigen (anti-HLA) antibodies against mismatched donor antigens significantly correlates with the development of bronchiolitis obliterans (BOS). Further, these anti-HLA antibodies are developed at least 15 months prior to any clinical evidence of BOS. This lag period between the development of anti-HLA antibodies and the onset of BOS gives us an opportunity to intervene to delay and/or prevent the development of BOS.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    778 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Immune Mechanisms of Rejection in Human Lung Allografts
    Actual Study Start Date :
    Jan 1, 1998
    Actual Primary Completion Date :
    Jul 1, 2017
    Actual Study Completion Date :
    Jul 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. The primary efficacy event is the change in pulmonary function testing values (FEV1). [Lung function is monitored at regular intervals. Patients will be followed for five years.]

    Secondary Outcome Measures

    1. Secondary efficacy measurements include allograft and patient survival, incidence of BOS and Obliterative bronchiolitis. [The subjects are monitored at regular intervals. Patients will be followed for five years.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Lung transplant recipient.
    Exclusion Criteria:

    • Pregnant women,

    • Prisoners, AND

    • Anyone who is unable or unwilling to consent to this study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Washington University School of Medicine
    • National Institutes of Health (NIH)

    Investigators

    • Principal Investigator: Thalachallour Mohanakumar, PhD, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT00861900
    Other Study ID Numbers:
    • 98-0977-201103312
    • HL056643
    First Posted:
    Mar 16, 2009
    Last Update Posted:
    Jun 19, 2018
    Last Verified:
    Jun 1, 2018
    Additional relevant MeSH terms:
    Bronchiolitis
    Bronchiolitis Obliterans

    Study Results

    No Results Posted as of Jun 19, 2018