Immune Mechanisms of Rejection in Human Lung Allografts

N/ACompletedNCT00861900

Washington University School of Medicine778 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

778

Conditions

Bronchiolitis Obliterans

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Lung transplant recipient. Exclusion Criteria: * Pregnant women, * Prisoners, AND * Anyone who is unable or unwilling to consent to this study.

Outcomes

Primary Outcomes

The primary efficacy event is the change in pulmonary function testing values (FEV1).

Time frame: Lung function is monitored at regular intervals. Patients will be followed for five years.

Secondary Outcomes

Secondary efficacy measurements include allograft and patient survival, incidence of BOS and Obliterative bronchiolitis.

Time frame: The subjects are monitored at regular intervals. Patients will be followed for five years.

Data from ClinicalTrials.gov

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