Immune Monitoring in Sensitized Patients at Risk of Rejection



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 65
Updated:1/9/2019
Start Date:August 20, 2015
End Date:September 8, 2017

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The purpose of this study is to test the effect of anti-rejection medications on your immune
system

Recipients of deceased or living donor transplants with calculated percent reactive antibody
(cPRA) of 50% or greater at University of California, San Francisco (UCSF) will be enrolled
in the trial. Samples for Kidney Solid Organ Response Test (kSORT) will be obtained
pre-transplant (and immunosuppression) and post-transplant (see Table 1). Urine will be
obtained at the same true intervals including pre-transplant in patients who still produce
urine to correlate with graft rejection, inflammation and kSORT. A piece (minimum 1/3 core)
of the protocol or for cause biopsy tissue will be saved in Ribonucleic acids (RNA) later for
gene expression analysis as a correlate of graft inflammation with the biopsy, kSORT and
urine. In addition, samples will be when patients are undergoing cause kidney biopsy, prior
to treatment intensification and procedure. Patient's who are treated for rejection, will
have additional samples obtained 2-4 weeks after treatment of rejection and at the time of
any followup biopsy for monitoring resolution of biopsy confirmed acute rejection.

Inclusion Criteria:

1. 18 years or older able to consent

2. No history of HIV, hepatitis C and active hepatitis B infection

3. cPRA ≥ 50%

Exclusion Criteria:

1. Patients on Coumadin

2. Human Leukocyte antigen (HLA) identical donor recipient patients
We found this trial at
1
site
San Francisco, California 94143
1341
mi
from
San Francisco, CA
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