<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/NCT03292029</url>
  </required_header>
  <id_info>
    <org_study_id>HD-T50-01-ES</org_study_id>
    <nct_id>NCT03292029</nct_id>
  </id_info>
  <brief_title>Pilot Medical Evaluation of the T50 Test</brief_title>
  <official_title>Pilot Medical Evaluation of the T50 Calcification Inhibition Test in NephroCare Clinics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fresenius Medical Care Deutschland GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fresenius Medical Care Deutschland GmbH</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>
      This pilot study aims to evaluate in an exploratory way the predictive power of a novel in&#xD;
      vitro test (T50 Calcification Inhibition Test, T50 CIT), which measures the mineralization&#xD;
      inhibition capacity of blood, in terms of its association with time to all-cause mortality in&#xD;
      haemodialysis patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Disturbances in mineral and bone metabolism centrally contribute to the exceedingly elevated&#xD;
      risk for cardiovascular (CV) disease in dialysis patients. A novel in vitro test (T50&#xD;
      Calcification Inhibition Test, T50 CIT) has been developed, which measures the mineralization&#xD;
      inhibition capacity of blood. This pilot study aims to exploratory examine the predictive&#xD;
      power of baseline T50 CIT and fetuin-A (protein which is centrally involved in the inhibition&#xD;
      of the formation of crystalline hydroxyapatite) values in terms of their association with&#xD;
      all-cause mortality in an unselected cohort of haemodialysis patients. Moreover, the study&#xD;
      shall investigate the association between baseline T50 CIT and fetuin-A values with CV&#xD;
      related mortality, all-cause hospitalization and CV related hospitalization. Finally, the&#xD;
      study aims to compare the predictive power of T50 CIT values with a set of six established&#xD;
      calcification-related parameters (albumin, phosphate, calcium, magnesium, bicarbonate and&#xD;
      fetuin-A). After baseline blood sampling the patients will be followed for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">March 4, 2020</completion_date>
  <primary_completion_date type="Actual">October 5, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Exploratory, interventional, open, multi-center, prospective</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>T50 CIT values</measure>
    <time_frame>Baseline after signed informed consent</time_frame>
    <description>The primary objective of this pilot study is to exploratory examine the predictive power of baseline T50 CIT values in terms of their association with time to all-cause mortality in haemodialysis patients.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">776</enrollment>
  <condition>Renal Failure</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Vascular Calcification</condition>
  <arm_group>
    <arm_group_label>T50 Calcification Inhibition Test (CIT)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Measurement of T50 CIT and fetuin-A serum values</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>T50 Calcification Inhibition Test (CIT)</intervention_name>
    <description>Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients</description>
    <arm_group_label>T50 Calcification Inhibition Test (CIT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent signed and dated by study patient and investigator/authorised&#xD;
             physician&#xD;
&#xD;
          -  Minimum age of 18 years&#xD;
&#xD;
          -  Incident and prevalent haemodialysis patients&#xD;
&#xD;
          -  Three haemodialysis treatments per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition which could interfere with the patient's ability to comply with the&#xD;
             study&#xD;
&#xD;
          -  Pregnancy (pregnancy test will be conducted with female patients aged &lt;= 55 years) or&#xD;
             lactation period&#xD;
&#xD;
          -  Participation in an interventional clinical study during the preceding 30 days&#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>Abraham Rincon Bello, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fresenius Medical Care Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Diálisis Barcelona - Glories</name>
      <address>
        <city>Barcelona</city>
        <zip>08013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Diálisis Barcelona - Diagonal</name>
      <address>
        <city>Barcelona</city>
        <zip>08019</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Diálisis Barcelona - Rosselló</name>
      <address>
        <city>Barcelona</city>
        <zip>08029</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Diálisis Granollers</name>
      <address>
        <city>Granollers</city>
        <zip>08401</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Diálisis Hospitalet</name>
      <address>
        <city>L'Hospitalet De Llobregat</city>
        <zip>08901</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Diálisis Reus</name>
      <address>
        <city>Reus</city>
        <zip>43205</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Diálisis Tarragona</name>
      <address>
        <city>Tarragona</city>
        <zip>43007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Diálisis Terrassa</name>
      <address>
        <city>Terrassa</city>
        <zip>08223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>February 8, 2022</last_update_submitted>
  <last_update_submitted_qc>February 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Renal replacement therapy</keyword>
  <keyword>Haemodialsysis</keyword>
  <keyword>Calcification Inhibition Test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Calcinosis</mesh_term>
    <mesh_term>Vascular Calcification</mesh_term>
  </condition_browse>
  <!-- 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/NCT03292029
org study id: HD-T50-01-ES
nct id: NCT03292029
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study aims to evaluate in an exploratory way the predictive power of a novel in
      vitro test (T50 Calcification Inhibition Test, T50 CIT), which measures the mineralization
      inhibition capacity of blood, in terms of its association with time to all-cause mortality in
      haemodialysis patients.
Disturbances in mineral and bone metabolism centrally contribute to the exceedingly elevated
      risk for cardiovascular (CV) disease in dialysis patients. A novel in vitro test (T50
      Calcification Inhibition Test, T50 CIT) has been developed, which measures the mineralization
      inhibition capacity of blood. This pilot study aims to exploratory examine the predictive
      power of baseline T50 CIT and fetuin-A (protein which is centrally involved in the inhibition
      of the formation of crystalline hydroxyapatite) values in terms of their association with
      all-cause mortality in an unselected cohort of haemodialysis patients. Moreover, the study
      shall investigate the association between baseline T50 CIT and fetuin-A values with CV
      related mortality, all-cause hospitalization and CV related hospitalization. Finally, the
      study aims to compare the predictive power of T50 CIT values with a set of six established
      calcification-related parameters (albumin, phosphate, calcium, magnesium, bicarbonate and
      fetuin-A). After baseline blood sampling the patients will be followed for 2 years.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Exploratory, interventional, open, multi-center, prospective
primary purpose: Other
masking: None (Open Label)
measure: T50 CIT values
time frame: Baseline after signed informed consent
description: The primary objective of this pilot study is to exploratory examine the predictive power of baseline T50 CIT values in terms of their association with time to all-cause mortality in haemodialysis patients.
arm group label: T50 Calcification Inhibition Test (CIT)
arm group type: Other
description: Measurement of T50 CIT and fetuin-A serum values
intervention type: Diagnostic Test
intervention name: T50 Calcification Inhibition Test (CIT)
description: Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients
arm group label: T50 Calcification Inhibition Test (CIT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abraham Rincon Bello, Dr.
role: Principal Investigator
affiliation: Fresenius Medical Care Spain
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Calcinosis
mesh term: Vascular Calcification