Immune Monitoring in Sensitized Patients at Risk of Rejection (PRISM)
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ClinicalTrials.gov Identifier: NCT03794817 |
Recruitment Status :
Completed
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
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Condition or disease |
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Kidney Failure |
Study Type : | Observational |
Actual Enrollment : | 112 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Immune Monitoring in Sensitized Patients at Risk of Rejection |
Actual Study Start Date : | August 20, 2015 |
Actual Primary Completion Date : | September 8, 2017 |
Actual Study Completion Date : | September 8, 2017 |
- Immune monitoring in sensitized patients at risk of rejection [ Time Frame: 2 years ]Pretransplant Kidney Solid Organ Response Test (kSORT) predictive value of rejection in the first 6 months after transplantation
- Kidney Solid Organ Response Test (kSORT) with pathological findings [ Time Frame: 2 years ]Correlation of kSORT with pathological findings on kidney biopsy
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 18 years or older able to consent
- No history of HIV, hepatitis C and active hepatitis B infection
- cPRA ≥ 50%
Exclusion Criteria:
- Patients on Coumadin
- Human Leukocyte antigen (HLA) identical donor recipient patients

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794817
United States, California | |
University of California San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Flavio Vincenti, M.D. | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT03794817 |
Other Study ID Numbers: |
PRISM |
First Posted: | January 7, 2019 Key Record Dates |
Last Update Posted: | January 7, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney transplant recipient |
Renal Insufficiency Kidney Diseases Urologic Diseases |