Immune Mechanisms of Rejection in Human Lung Allografts

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00861900
First received: March 13, 2009
Last updated: July 14, 2009
Last verified: July 2009
  Purpose

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
Bronchiolitis Obliterans

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Mechanisms of Rejection in Human Lung Allografts

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: January 1998
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patient who is a candidate for a lung transplant.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861900

Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Thalachallour Mohanakumar, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Mohanakumar, Thalachallour PHD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00861900     History of Changes
Other Study ID Numbers: 98-0977, HL056643
Study First Received: March 13, 2009
Last Updated: July 14, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 30, 2014