View Clinical Trial (Medical Research Study)
Prospective Donor Specific Antibody (DSA) Monitoring Protocol To Detect Patient Characteristics and /or Changes In Immunosuppression on the Development of De Novo Antibodies
| City: |
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Spokane |
| State: |
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Washington |
| Zip Code: |
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99204 |
| Conditions: |
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Kidney Transplant - Kidney/Pancreas Transplant |
| Purpose: |
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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.
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| Study Summary: |
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Organ transplantation is an effective treatment for several end-stage organ diseases.
Preventing rejection of transplanted organs remains the premier challenge. According to the
humoral theory, donor specific antibodies (DSA) are the major cause of chronic rejection and
allograft loss. Despite this, and evidence that links human leukocyte antigen (HLA)
antibodies to allograft dysfunction and loss, doubt remains about the cause-and-effect
relationship and confirmation of this evidence is necessary to help facilitate change in
transplant practice. Prospective monitoring for de novo DSA in the serum of patients who
have received a transplant may allow for earlier detection, evaluation, and characterization
of factors leading to the development of antibodies prior to the development of clinical
manifestations of graft dysfunction.
The contribution of the major histocompatibility complex (MHC) Class I and Class II
antibodies to transplant outcomes is well documented. However, there is emerging evidence
that antibody mediated rejection and the severity of outcomes may involve proteins and
antibodies that go beyond HLA Class I and II. A number of assays are available for testing
for these additional antibodies and proteins but they are currently not used for widespread
patient monitoring in part due to lack of data justifying their commercial use. This pilot
study will prospectively evaluate for the presence and/or emergence of these unique
antibodies, (I.E. MICA antigen, IgG3 and C1Q) in serial samples of serum, and confirm or
reject the utility of incorporating these assays into routine patient monitoring which
might provide earlier evidence of emerging rejection. Serum samples will be stored
indefinitely for future kidney transplant research projects.
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| Criteria: |
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Inclusion Criteria:
- Have received a living donor or deceased donor kidney/kidney pancreas transplant
Exclusion Criteria:
- Have not received a transplant
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| NCT ID: |
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NCT01382355 |
| Primary Contact: |
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Principal Investigator
Angela Q Maldonado, PharmD
Providence Sacred Heart Medical Center
Angela Q Maldonado, PharmD
Phone: 5094746993
Email: angela.maldonado@providence.org
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| Backup Contact: |
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Email: beth.aaron@providence.org
Beth C Aaron, CCRC
Phone: 5092306001
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| Location Contact: |
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Spokane, Washington 99204
United States
Angela Q Maldonado, PharmD
Phone: 509-474-6993
Email: angela.maldonado@providence.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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