<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/NCT03274921</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/16/8250</org_study_id>
    <secondary_id>University Hospital Toulouse</secondary_id>
    <nct_id>NCT03274921</nct_id>
  </id_info>
  <brief_title>Biomarkers of Cardiovascular Complications in Chronic Kidney Disease</brief_title>
  <acronym>BioClaCK</acronym>
  <official_title>Identification of BIOmarkers for Detection and Understanding of Cardiovascular Complications in Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      Identification of new retention solutes associated with cardiovascular (CV) toxicity in&#xD;
      Chronic Kidney Disease (CKD) patients will help to better understand the pathophysiological&#xD;
      mechanisms at stake and to prevent CKD-associated mortality and morbidity. For a molecule to&#xD;
      be defined as a toxic retention solute, plasma accumulation in the course of CKD has to be&#xD;
      demonstrated but also proof needs to be made that plasma accumulation during CKD is indeed&#xD;
      associated with an increased risk of CV complications. Moreover, precise determination of the&#xD;
      plasma concentration has to be performed in order to later study in vitro and in vivo the&#xD;
      toxic mechanisms involved. Based on previous results of plasma proteome analysis using mass&#xD;
      spectrometry, a previous study has selected 10 promising protein candidates. These proteins&#xD;
      accumulated in the plasma of patients during CKD progression and are known to be associated&#xD;
      with CV events in non-CKD patients. The objective of the present study is now to 1) evaluate&#xD;
      the association of the plasma accumulation of the 10 retention solutes with CV complications&#xD;
      in CKD patients and 2) determine their plasma concentration using ELISA. One hundred and&#xD;
      seventy six patients with advanced CKD will be included and divided in 2 groups: 44 patients&#xD;
      with history of CV complications in the past 4 years and 132 patients free of any CV&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Plasma accumulation of new retention solutes</measure>
    <time_frame>Day 0</time_frame>
    <description>evaluate the plasma accumulation of the 10 retention solutes using mass spectrometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>determine their plasma concentration</measure>
    <time_frame>Day 0</time_frame>
    <description>determine their plasma concentration using ELISA</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">130</enrollment>
  <condition>Chronic Renal Disease</condition>
  <arm_group>
    <arm_group_label>Cardiovascular complication</arm_group_label>
    <description>patients with history of CV complications in the past 4 years had biological determination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No cardiovascular complication</arm_group_label>
    <description>patients free of any CV complications had biological determination</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Biological determination</intervention_name>
    <description>Evaluation of plasma accumulation of the 10 retention solutes with CV complications in CKD patients</description>
    <arm_group_label>Cardiovascular complication</arm_group_label>
    <arm_group_label>No cardiovascular complication</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cohort of patients consulting in University Hospital toulouse&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with stage 4 or 5 CKD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient with stage 1, 2 or 3 CKD&#xD;
&#xD;
          -  patient with solid tumor&#xD;
&#xD;
          -  patient with malignant blood disease&#xD;
&#xD;
          -  patient with acute kidney disease in the past 3 months&#xD;
&#xD;
          -  patient with acute glomerulonephritis in the past 6 months.&#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_official>
    <last_name>Stanislas FAGUER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hosptial Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiovascular complications</keyword>
  <keyword>biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Kidney Failure, Chronic</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/NCT03274921
org study id: RC31/16/8250
secondary id: University Hospital Toulouse
nct id: NCT03274921
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Identification of new retention solutes associated with cardiovascular (CV) toxicity in
      Chronic Kidney Disease (CKD) patients will help to better understand the pathophysiological
      mechanisms at stake and to prevent CKD-associated mortality and morbidity. For a molecule to
      be defined as a toxic retention solute, plasma accumulation in the course of CKD has to be
      demonstrated but also proof needs to be made that plasma accumulation during CKD is indeed
      associated with an increased risk of CV complications. Moreover, precise determination of the
      plasma concentration has to be performed in order to later study in vitro and in vivo the
      toxic mechanisms involved. Based on previous results of plasma proteome analysis using mass
      spectrometry, a previous study has selected 10 promising protein candidates. These proteins
      accumulated in the plasma of patients during CKD progression and are known to be associated
      with CV events in non-CKD patients. The objective of the present study is now to 1) evaluate
      the association of the plasma accumulation of the 10 retention solutes with CV complications
      in CKD patients and 2) determine their plasma concentration using ELISA. One hundred and
      seventy six patients with advanced CKD will be included and divided in 2 groups: 44 patients
      with history of CV complications in the past 4 years and 132 patients free of any CV
      complications.
observational model: Cohort
time perspective: Prospective
measure: Plasma accumulation of new retention solutes
time frame: Day 0
description: evaluate the plasma accumulation of the 10 retention solutes using mass spectrometry
measure: determine their plasma concentration
time frame: Day 0
description: determine their plasma concentration using ELISA
arm group label: Cardiovascular complication
description: patients with history of CV complications in the past 4 years had biological determination
arm group label: No cardiovascular complication
description: patients free of any CV complications had biological determination
intervention type: Diagnostic Test
intervention name: Biological determination
description: Evaluation of plasma accumulation of the 10 retention solutes with CV complications in CKD patients
arm group label: Cardiovascular complication
arm group label: No cardiovascular complication
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stanislas FAGUER, MD
role: Principal Investigator
affiliation: University Hosptial Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Kidney Failure, Chronic
sharing ipd: No