Immune Monitoring in Sensitized Patients at Risk of Rejection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Immune monitoring in sensitized patients at risk of rejection
Study Overview
Brief Summary
The purpose of this study is to test the effect of anti-rejection medications on your immune system
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older able to consent
- •No history of HIV, hepatitis C and active hepatitis B infection
Exclusion Criteria
- •Patients on Coumadin
- •Human Leukocyte antigen (HLA) identical donor recipient patients
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Kidney Solid Organ Response Test (kSORT) with pathological findings(2 years)
