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Immune Monitoring in Sensitized Patients at Risk of Rejection (PRISM)

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Kidney Failure

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

112 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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