<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/NCT04506060</url>
  </required_header>
  <id_info>
    <org_study_id>PI2020_843_0101</org_study_id>
    <nct_id>NCT04506060</nct_id>
  </id_info>
  <brief_title>Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation</brief_title>
  <acronym>BKSEREIN</acronym>
  <official_title>Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</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>
      Due to the increasing importance of BKV infection on the survival of kidney transplants, a&#xD;
      better knowledge, in the pretransplant phase, of the risk factors leading to viral&#xD;
      reactivation could allow the follow-up physician to be more vigilant and better prevent this&#xD;
      pathology. There are no commercial tests for BKV serology. In the virology laboratory, the&#xD;
      investigators have developed the technique for producing &quot;Virus-like particles&quot; (VLP) that&#xD;
      mimics the antigenic structure of the BK virus. The investigators plan to evaluate&#xD;
      seroreactivity to the five BK virus serotypes in the recipient of a kidney transplant as a&#xD;
      pretransplant and to compare this data with the detection or not of viral reactivation in the&#xD;
      recipient during the first post-transplant year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient</measure>
    <time_frame>one year</time_frame>
    <description>Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient. Optical density of serum antibody titer will be obtained by Elisa.</description>
  </primary_outcome>
  <enrollment type="Anticipated">378</enrollment>
  <condition>BK Virus Nephropathy</condition>
  <condition>Risk Factor</condition>
  <condition>Kidney Transplantation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>serum withdrawal</intervention_name>
    <description>Serum of the transplant patient. In the transplanted patient, the search for the BK virus is traditionally carried out during visits in the first year after transplantation.</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum of the transplant patient. In the transplanted patient, the search for the BK virus is&#xD;
      traditionally carried out during visits in the first year after transplantation.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Renal transplant patients with regular virological follow-up (blood and urine for BKV)&#xD;
        during the first year after transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult kidney transplanted patients&#xD;
&#xD;
          -  Renal transplant patients with regular virological follow-up (blood and urine for BKV)&#xD;
             during the first year after transplantation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Renal transplant patients with no follow-up for one year after transplantation&#xD;
             (transplant failure, return to dialysis, death, follow-up outside the transplant&#xD;
             centre)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Etienne Brochot, MD</last_name>
    <phone>(33)322087064</phone>
    <email>brochot.etienne@chu-amiens.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80480</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Etienne Brochot, MD</last_name>
      <phone>(33)322087064</phone>
      <email>brochot.etienne@chu-amiens.fr</email>
    </contact>
    <contact_backup>
      <last_name>Etienne Brochot</last_name>
      <phone>(33)322087064</phone>
      <email>brochot.etienne@chu-amiens.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Maité Jaureguy, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BK Virus Nephropathy</keyword>
  <keyword>risk factor</keyword>
  <keyword>kidney transplantation</keyword>
  <keyword>viral serology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</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/NCT04506060
org study id: PI2020_843_0101
nct id: NCT04506060
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Due to the increasing importance of BKV infection on the survival of kidney transplants, a
      better knowledge, in the pretransplant phase, of the risk factors leading to viral
      reactivation could allow the follow-up physician to be more vigilant and better prevent this
      pathology. There are no commercial tests for BKV serology. In the virology laboratory, the
      investigators have developed the technique for producing "Virus-like particles" (VLP) that
      mimics the antigenic structure of the BK virus. The investigators plan to evaluate
      seroreactivity to the five BK virus serotypes in the recipient of a kidney transplant as a
      pretransplant and to compare this data with the detection or not of viral reactivation in the
      recipient during the first post-transplant year.
observational model: Case-Only
time perspective: Prospective
measure: Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient
time frame: one year
description: Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient. Optical density of serum antibody titer will be obtained by Elisa.
intervention type: Other
intervention name: serum withdrawal
description: Serum of the transplant patient. In the transplanted patient, the search for the BK virus is traditionally carried out during visits in the first year after transplantation.
Serum of the transplant patient. In the transplanted patient, the search for the BK virus is
      traditionally carried out during visits in the first year after transplantation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Etienne Brochot, MD
phone: (33)322087064
email: brochot.etienne@chu-amiens.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Kidney Diseases
sharing ipd: No