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Clinical Trials/NCT03794817
NCT03794817
Completed
Not Applicable

Immune Monitoring in Sensitized Patients at Risk of Rejection

University of California, San Francisco1 site in 1 country112 target enrollmentAugust 20, 2015
ConditionsKidney Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Failure
Sponsor
University of California, San Francisco
Enrollment
112
Locations
1
Primary Endpoint
Immune monitoring in sensitized patients at risk of rejection
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 20, 2015
End Date
September 8, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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