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Prospective Donor Specific Antibody (DSA) Monitoring Protocol

NCT01382355 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2011-08-04

No results posted yet for this study

Summary

Advances in transplant pharmacotherapy have led to improved one-year patient and graft survival in kidney transplant recipients, but have not translated to enhanced long-term survival. An explanation for the disparity in outcomes is the negative role of antibodies in transplant graft survival. There currently does not exist maintenance immunosuppression that targets antibodies and standard of practice aims at removing circulating donor specific antibodies upon detection of antibody mediated graft damage but not prior to the detection of rejection. There exists an insufficiency of data regarding patient and donor characteristics, changes in immunosuppression, the risk of viral donor and patient seropositivity and the risk of non-compliance on the development of antibodies. By measuring antibody levels in the blood at specific time periods after transplant, we may have a better understanding of what types of patients will develop antibodies, when these antibodies appear and how changes to transplant medications may affect antibodies.

The proposed project will examine the multifactorial risks associated with the development and appearance of donor-specific antibodies in the first year post-kidney transplant. The data collected will provide a historical perspective and preliminary pilot data to support a proposal for prospective antibody monitoring and to justify pre-emptively treating the antibodies in the absence of clinical signs of rejection.

Conditions

  • Kidney Transplant
  • Kidney/Pancreas Transplant

Sponsors & Collaborators

  • Washington State University

    collaborator OTHER

  • Paul I Terasaki Foundation Laboratory

    collaborator UNKNOWN

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Angela Q Maldonado, PharmD · Providence Sacred Heart Medical Center

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382355 on ClinicalTrials.gov