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/NCT05963126</url>
    </required_header>
    <id_info>
      <org_study_id>MHUFA-hypertension CKD</org_study_id>
      <secondary_id>RVO-FNOs/2023 17</secondary_id>
      <nct_id>NCT05963126</nct_id>
    </id_info>
    <brief_title>Fetuin A as a Predictor of Deterioration of Renal Function in Hypertonic Patients</brief_title>
    <official_title>Modified Urine Fetuin A as a Predictor of Deterioration of Renal Function in Patients With Resistant and Non-resistant Hypertension</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Ostrava</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital Ostrava</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>
        Commonly used parameters (creatinine, estimated glomerular filtration rate, and urine&#xD;
        albumin/creatinine ratio) for prediction of decline of renal function are sensitive for&#xD;
        advanced kidney impairment. Modified human urine Fetuin A (urine Fetuin A) with specific&#xD;
        modification in urine (Fetuin A) can earlier predict the progression of kidney disease in&#xD;
        patients with diabetes. Studies evaluating urine Fetuin A in hypertonic patients are still&#xD;
        lacking.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Arterial hypertension and diabetes are the most common cause of chronic kidney disease.&#xD;
        Commonly used parameters for the evaluation of renal function (plasma creatinine, estimated&#xD;
        glomerular filtration rate, and urine albumin/creatinine ratio) are sensitive to advanced&#xD;
        kidney disease. Parameters predicting early kidney impairment are still lacking. Modified&#xD;
        human urine Fetuin A with specific modification in urine (urine Fetuin A) presents a new&#xD;
        biomarker that seems to be promising in the early prediction of kidney disease in patients&#xD;
        with diabetes without microalbuminuria. Studies evaluating urine Fetuin A in hypertonic&#xD;
        patients are still lacking.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>Glomerular filtration rate</measure>
      <time_frame>1 year</time_frame>
      <description>Decline of glomerular filtration rate in 1-year follow-up of each patient in a total of 3 visits at times: 0 months, 6 months, and 12 months.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Urine biomarker DNLite IVD103 - primary aim</measure>
      <time_frame>1 year</time_frame>
      <description>Evaluation of urine biomarker DNLite IVD103 and its ability to predict deterioration of renal function defined as a decline of glomerular filtration rate in patients with arterial hypertension, resistant arterial hypertension, and secondary hypertension. Diabetic nephropathy in vitro diagnostics (DNLite IVD103) is a colorimetric immunoassay intended for quantitative measurement of unique Fetuin-A with specific post-translational modification in human urine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine biomarker DNLite IVD103 - secondary aim</measure>
      <time_frame>1 year</time_frame>
      <description>Evaluation of urine biomarker DNLite IVD103 and its ability to predict deterioration of renal function defined in patients with manifested cardiovascular disease, dyslipidemia (yes/no).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine biomarker DNLite IVD103 - correlation</measure>
      <time_frame>1 year</time_frame>
      <description>Evaluation of the correlation of biomarker DNLite IVD103 in patients' plasma and in urine (yes/no).</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Arterial Hypertension</condition>
    <arm_group>
      <arm_group_label>Patients with hypertension, resistant hypertension, and secondary hypertension</arm_group_label>
      <description>Patients with arterial hypertension, resistant arterial hypertension, and secondary hypertension.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention.</intervention_name>
      <description>No intervention.</description>
      <arm_group_label>Patients with hypertension, resistant hypertension, and secondary hypertension</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Samples of urine.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with hypertension and resistant hypertension followed-up in the Hypertension&#xD;
          excellence centre and Lipid centre in University Hospital Ostrava.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Arterial hypertension treated by at least one antihypertensive agent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diabetes mellitus of any type, defined as fasting glucose &gt;7,0 mmol/l or any glycemia&#xD;
               &gt;11,0 mmol/l, or HbA1c&gt;48 mmol/mol&#xD;
  &#xD;
            -  Decompensated arterial hypertension defined as office blood pressure &gt;180/110 mmHg or&#xD;
               on Ambulatory Blood Pressure Monitoring (ABPM)&#xD;
  &#xD;
            -  Patient with renal replacement therapy&#xD;
  &#xD;
            -  Present rheumatoid disease (rheumatoid arthritis, systemic lupus, sclerodermia,&#xD;
               dermatomyositis, Inflammatory Bowel Disease, etc.), positivity of antinuclear antibody&#xD;
               (ANA) / extractable nuclear antigen (ENA) screening&#xD;
  &#xD;
            -  Acute infection defined as C-Reactive Protein (CRP) &gt;50 mg/l&#xD;
  &#xD;
            -  Severe impairment of liver function defined as cirrhosis, Alanine Transaminase or&#xD;
               ASpartate Transferase (ALT or AST) &gt;10 µkat/l&#xD;
  &#xD;
            -  Terminal incurable illness&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zdeněk Ramík, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital Ostrava</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jiří Hynčica</last_name>
      <phone>0042059737</phone>
      <phone_ext>2587</phone_ext>
      <email>jiri.hyncica@fno.cz</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Hospital Ostrava, - Department of Internal Medicine and Cardiology</name>
        <address>
          <city>Ostrava</city>
          <state>Czech Republic</state>
          <zip>70852</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jiří Hynčica</last_name>
        <phone>0042059737</phone>
        <phone_ext>2587</phone_ext>
        <email>jiri.hyncica@fno.cz</email>
      </contact>
      <investigator>
        <last_name>Zdeněk Ramík, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Iveta Bystroňová, MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Janula Stromská, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Pavla Jadrníčková, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lukáš Štos, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Eva Široká</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <link>
      <url>https://bpmbiotech.com</url>
      <description>The DNlite Test - Products - BIOPREVENTIVE MEDICINE</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Arterial Hypertension</keyword>
    <keyword>Resistant Arterial Hypertension</keyword>
    <keyword>Chronic Kidney Disease</keyword>
    <keyword>Fetuin A</keyword>
    <keyword>DNLite IVD103</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no plan to share individual participant data with other researchers.</ipd_description>
    </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/NCT05963126
  org study id: MHUFA-hypertension CKD
  secondary id: RVO-FNOs/2023 17
  nct id: NCT05963126
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Commonly used parameters (creatinine, estimated glomerular filtration rate, and urine
        albumin/creatinine ratio) for prediction of decline of renal function are sensitive for
        advanced kidney impairment. Modified human urine Fetuin A (urine Fetuin A) with specific
        modification in urine (Fetuin A) can earlier predict the progression of kidney disease in
        patients with diabetes. Studies evaluating urine Fetuin A in hypertonic patients are still
        lacking.
  Arterial hypertension and diabetes are the most common cause of chronic kidney disease.
        Commonly used parameters for the evaluation of renal function (plasma creatinine, estimated
        glomerular filtration rate, and urine albumin/creatinine ratio) are sensitive to advanced
        kidney disease. Parameters predicting early kidney impairment are still lacking. Modified
        human urine Fetuin A with specific modification in urine (urine Fetuin A) presents a new
        biomarker that seems to be promising in the early prediction of kidney disease in patients
        with diabetes without microalbuminuria. Studies evaluating urine Fetuin A in hypertonic
        patients are still lacking.
  observational model: Cohort
  time perspective: Prospective
  measure: Glomerular filtration rate
  time frame: 1 year
  description: Decline of glomerular filtration rate in 1-year follow-up of each patient in a total of 3 visits at times: 0 months, 6 months, and 12 months.
  measure: Urine biomarker DNLite IVD103 - primary aim
  time frame: 1 year
  description: Evaluation of urine biomarker DNLite IVD103 and its ability to predict deterioration of renal function defined as a decline of glomerular filtration rate in patients with arterial hypertension, resistant arterial hypertension, and secondary hypertension. Diabetic nephropathy in vitro diagnostics (DNLite IVD103) is a colorimetric immunoassay intended for quantitative measurement of unique Fetuin-A with specific post-translational modification in human urine.
  measure: Urine biomarker DNLite IVD103 - secondary aim
  time frame: 1 year
  description: Evaluation of urine biomarker DNLite IVD103 and its ability to predict deterioration of renal function defined in patients with manifested cardiovascular disease, dyslipidemia (yes/no).
  measure: Urine biomarker DNLite IVD103 - correlation
  time frame: 1 year
  description: Evaluation of the correlation of biomarker DNLite IVD103 in patients' plasma and in urine (yes/no).
  arm group label: Patients with hypertension, resistant hypertension, and secondary hypertension
  description: Patients with arterial hypertension, resistant arterial hypertension, and secondary hypertension.
  intervention type: Other
  intervention name: No intervention.
  description: No intervention.
  arm group label: Patients with hypertension, resistant hypertension, and secondary hypertension
  Samples of urine.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Zdeněk Ramík, MD
  role: Principal Investigator
  affiliation: University Hospital Ostrava
  last name: Jiří Hynčica
  phone: 0042059737
  phone ext: 2587
  email: jiri.hyncica@fno.cz
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Czechia
  url: https://bpmbiotech.com
  description: The DNlite Test - Products - BIOPREVENTIVE MEDICINE
  responsible party type: Sponsor
  mesh term: Hypertension
  sharing ipd: No
  ipd description: There is no plan to share individual participant data with other researchers.