<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03794817</url>
  </required_header>
  <id_info>
    <org_study_id>PRISM</org_study_id>
    <nct_id>NCT03794817</nct_id>
  </id_info>
  <brief_title>Immune Monitoring in Sensitized Patients at Risk of Rejection</brief_title>
  <acronym>PRISM</acronym>
  <official_title>Immune Monitoring in Sensitized Patients at Risk of Rejection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the effect of anti-rejection medications on your immune&#xD;
      system&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recipients of deceased or living donor transplants with calculated percent reactive antibody&#xD;
      (cPRA) of 50% or greater at University of California, San Francisco (UCSF) will be enrolled&#xD;
      in the trial. Samples for Kidney Solid Organ Response Test (kSORT) will be obtained&#xD;
      pre-transplant (and immunosuppression) and post-transplant (see Table 1). Urine will be&#xD;
      obtained at the same true intervals including pre-transplant in patients who still produce&#xD;
      urine to correlate with graft rejection, inflammation and kSORT. A piece (minimum 1/3 core)&#xD;
      of the protocol or for cause biopsy tissue will be saved in Ribonucleic acids (RNA) later for&#xD;
      gene expression analysis as a correlate of graft inflammation with the biopsy, kSORT and&#xD;
      urine. In addition, samples will be when patients are undergoing cause kidney biopsy, prior&#xD;
      to treatment intensification and procedure. Patient's who are treated for rejection, will&#xD;
      have additional samples obtained 2-4 weeks after treatment of rejection and at the time of&#xD;
      any followup biopsy for monitoring resolution of biopsy confirmed acute rejection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2015</start_date>
  <completion_date type="Actual">September 8, 2017</completion_date>
  <primary_completion_date type="Actual">September 8, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Immune monitoring in sensitized patients at risk of rejection</measure>
    <time_frame>2 years</time_frame>
    <description>Pretransplant Kidney Solid Organ Response Test (kSORT) predictive value of rejection in the first 6 months after transplantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kidney Solid Organ Response Test (kSORT) with pathological findings</measure>
    <time_frame>2 years</time_frame>
    <description>Correlation of kSORT with pathological findings on kidney biopsy</description>
  </secondary_outcome>
  <enrollment type="Actual">112</enrollment>
  <condition>Kidney Failure</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have received a kidney transplant and will be taking immunosuppressive&#xD;
        medications.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years or older able to consent&#xD;
&#xD;
          2. No history of HIV, hepatitis C and active hepatitis B infection&#xD;
&#xD;
          3. cPRA ≥ 50%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients on Coumadin&#xD;
&#xD;
          2. Human Leukocyte antigen (HLA) identical donor recipient patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Flavio Vincenti, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Kidney transplant recipient</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03794817
org study id: PRISM
nct id: NCT03794817
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the effect of anti-rejection medications on your immune
      system
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.
observational model: Cohort
time perspective: Prospective
measure: Immune monitoring in sensitized patients at risk of rejection
time frame: 2 years
description: Pretransplant Kidney Solid Organ Response Test (kSORT) predictive value of rejection in the first 6 months after transplantation
measure: Kidney Solid Organ Response Test (kSORT) with pathological findings
time frame: 2 years
description: Correlation of kSORT with pathological findings on kidney biopsy
Blood and urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Flavio Vincenti, M.D.
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Renal Insufficiency
sharing ipd: No