Prospective Donor Specific Antibody (DSA) Monitoring Protocol
Status unconfirmed
Conditions studied: Kidney Transplant, Kidney/Pancreas Transplant
In brief
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.
Key facts
- Study ID
- NCT01382355
- Run by
- Providence Health & Services
- People needed
- 60
- Starts
- 2011-08-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2011-08-04
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have received a living donor or deceased donor kidney/kidney pancreas transplant
You may not qualify if…
- Have not received a transplant
Where it is running
- Providence Sacred Heart Medical Center — Spokane, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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