Immune Mechanisms of Rejection in Human Lung Allografts

Completed

• Conditions: Bronchiolitis Obliterans

• Registration Number: NCT00861900
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-01
• Study First Submitted: 2009-03-13
• Study First Submitted QC: 2009-03-13
• Study First Posted: 2009-03-16
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-15
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 778

Inclusion Criteria

• Lung transplant recipient.

Exclusion Criteria

• Pregnant women,
• Prisoners, AND
• Anyone who is unable or unwilling to consent to this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.