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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794817
Recruitment Status : Completed
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
The purpose of this study is to test the effect of anti-rejection medications on your immune system

Condition or disease
Kidney Failure

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
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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
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. 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
Blood and urine

Eligibility Criteria
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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
Study Population
Patients who have received a kidney transplant and will be taking immunosuppressive medications.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Flavio Vincenti, M.D. University of California, San Francisco
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Kidney transplant recipient
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases