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OpenTrials
Completed

NCT Number: NCT03794817

Immune Monitoring in Sensitized Patients at Risk of Rejection

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

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Kidney Solid Organ Response Test (kSORT) with pathological findings

    Time frame: 2 years

    Correlation of kSORT with pathological findings on kidney biopsy

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: PRISM

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 7, 2019
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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