xml: <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/NCT06037109</url>
    </required_header>
    <id_info>
      <org_study_id>B3166-CTPR03</org_study_id>
      <nct_id>NCT06037109</nct_id>
    </id_info>
    <brief_title>VIDAS® NEPHROCLEAR Reference Interval Study</brief_title>
    <official_title>VIDAS® NEPHROCLEAR CCL14 Reference Interval Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BioMérieux</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>BioMérieux</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a multi-center sample analysis study in which urine samples previously collected from&#xD;
        apparently healthy adult subjects, and subjects with stable chronic morbidities but without&#xD;
        AKI in order to establish the reference range for the VIDAS® NEPHROCLEAR™ CCL14 test.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in conjunction with clinical&#xD;
        evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI),&#xD;
        as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥&#xD;
        72 hours) within 48 hours of patient assessment.&#xD;
  &#xD;
        The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or&#xD;
        older.&#xD;
  &#xD;
        The objective of this study is to determine the reference range for CCL14 concentration in&#xD;
        Apparently Healthy Adults and Adults with Chronic, Stable Morbidities&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 18, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>CCL14 concentration in urine</measure>
      <time_frame>Samples tested within 2 years of collection</time_frame>
      <description>CCL14 concentration will be measured using the VIDAS Necphroclear CCL14 Assay</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">585</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Apparently Healthy Adults</arm_group_label>
      <description>Apparently healthy adults (age ≥ 21 years); who have provided written informed consent for sample use in this study</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Adults with Chronic, Stable Morbidities</arm_group_label>
      <description>Adults (age ≥ 21 years);with one or more of the following chronic, stable morbid conditions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test</intervention_name>
      <description>Previously collected urine samples will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test</description>
      <arm_group_label>Adults with Chronic, Stable Morbidities</arm_group_label>
      <arm_group_label>Apparently Healthy Adults</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Urine samples&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Samples were collected from apparently healthy adults (n = ~300) and adults with&#xD;
          pre-specified underlying chronic stable morbidities (n = ~300).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Cohort A&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  a) Apparently healthy adults (age ≥ 21 years); b) Provide written informed consent for&#xD;
               study (AST-017) participation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  a) Any known or suspected acute illness or condition - including acute infections - at&#xD;
               the time of enrollment or within the previous 30 days; b) Any known or suspected&#xD;
               significant new onset or chronic morbid medical condition such as: Active cancer&#xD;
               Arrhythmia (atrial fibrillation, heart block, ventricular tachycardia) Chronic&#xD;
               coagulation abnormality Chronic obstructive pulmonary disease (including emphysema,&#xD;
               chronic bronchitis, and asthma) Chronic pancreatitis Chronic renal insufficiency&#xD;
               Congestive heart failure Coronary artery disease Diabetes mellitus (Type 1 or Type 2)&#xD;
               Gout Hyper- or hypothyroidism Hyperlipidemia (includes hypercholesterolemia)&#xD;
               Hypertension Immunocompromised Inflammatory bowel disease (including Crohn's disease&#xD;
               and ulcerative colitis) Liver cirrhosis Neuromuscular disease Peripheral vascular&#xD;
               disease (a.k.a. peripheral artery disease) Polycystic kidney disease Rheumatoid&#xD;
               arthritis Systemic Lupus Erythematosus c) Trauma-related surgery within the last 6&#xD;
               months; d) Any surgery, hospitalization or institutionalization (such as in a nursing&#xD;
               home) during the previous 3 months; e) Received any blood product transfusion within&#xD;
               the previous 2 months; f) Pregnant women or children; g) Prisoners or&#xD;
               institutionalized individuals; h) Already provided a urine sample for the AST-017&#xD;
               study&#xD;
  &#xD;
          Cohort B Inclusion Criteria Adults (age ≥ 21 years); b) One or more of the following&#xD;
          chronic, stable morbid conditions: Active cancer Arrhythmia (atrial fibrillation, heart&#xD;
          block, ventricular tachycardia) Chronic coagulation abnormality Chronic obstructive&#xD;
          pulmonary disease (including emphysema, chronic bronchitis, and asthma) Chronic&#xD;
          pancreatitis Chronic renal insufficiency Congestive heart failure Coronary artery disease&#xD;
          Diabetes mellitus (Type 1 or Type 2) Gout Hyper- or hypothyroidism Hyperlipidemia (includes&#xD;
          hypercholesterolemia) Hypertension Immunocompromised Inflammatory bowel disease (including&#xD;
          Crohn's disease and ulcerative colitis) Liver cirrhosis Neuromuscular disease Peripheral&#xD;
          vascular disease (a.k.a. peripheral artery disease) Polycystic kidney disease Rheumatoid&#xD;
          arthritis Systemic Lupus Erythematosus&#xD;
  &#xD;
          c) Provide written informed consent for study participation.&#xD;
  &#xD;
          For Cohort B subjects in the AST-017 Study:&#xD;
  &#xD;
          Subjects were considered to have the above condition(s) if he/she had the diagnosis by a&#xD;
          healthcare professional and/or was under treatment by a healthcare professional for the&#xD;
          listed condition(s).&#xD;
  &#xD;
          Subjects with a condition (e.g., hypertension, hypercholesterolemia) controlled by&#xD;
          medications were enrolled.&#xD;
  &#xD;
          To be considered chronic and stable, the condition(s) must have been present for at least 1&#xD;
          year and without any acute change (decompensation or improvement) within the 3 months prior&#xD;
          to enrollment.&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            1. Any known or suspected acute illness or condition - including acute infections - at&#xD;
               the time of enrollment or within the previous 30 days;&#xD;
  &#xD;
            2. Any new onset or unstable morbidities;&#xD;
  &#xD;
            3. Trauma-related surgery within the last 6 months;&#xD;
  &#xD;
            4. Any surgery, hospitalization or institutionalization (such as in a nursing home)&#xD;
               during the previous 3 months;&#xD;
  &#xD;
            5. Received any blood product transfusion within the previous 2 months;&#xD;
  &#xD;
            6. Pregnant women or children;&#xD;
  &#xD;
            7. Prisoners or institutionalized individuals;&#xD;
  &#xD;
            8. Already provided a urine sample for this (AST-017) study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>George Washington University</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20052</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Illinois Chicago</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60612</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037109
  org study id: B3166-CTPR03
  nct id: NCT06037109
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  This is a multi-center sample analysis study in which urine samples previously collected from
        apparently healthy adult subjects, and subjects with stable chronic morbidities but without
        AKI in order to establish the reference range for the VIDAS® NEPHROCLEAR™ CCL14 test.
  The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in conjunction with clinical
        evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI),
        as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥
        72 hours) within 48 hours of patient assessment.
  
        The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or
        older.
  
        The objective of this study is to determine the reference range for CCL14 concentration in
        Apparently Healthy Adults and Adults with Chronic, Stable Morbidities
  observational model: Cohort
  time perspective: Retrospective
  measure: CCL14 concentration in urine
  time frame: Samples tested within 2 years of collection
  description: CCL14 concentration will be measured using the VIDAS Necphroclear CCL14 Assay
  arm group label: Apparently Healthy Adults
  description: Apparently healthy adults (age ≥ 21 years); who have provided written informed consent for sample use in this study
  arm group label: Adults with Chronic, Stable Morbidities
  description: Adults (age ≥ 21 years);with one or more of the following chronic, stable morbid conditions.
  intervention type: Device
  intervention name: Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test
  description: Previously collected urine samples will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test
  arm group label: Adults with Chronic, Stable Morbidities
  arm group label: Apparently Healthy Adults
  Urine samples
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No