<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/NCT03307707</url>
  </required_header>
  <id_info>
    <org_study_id>CKD-MBD-HF</org_study_id>
    <nct_id>NCT03307707</nct_id>
  </id_info>
  <brief_title>New Heart Failure Biomarkers in Early Stage Chronic Kidney Disease-Mineral and Bone Disorder</brief_title>
  <acronym>CKD-MBD-HF</acronym>
  <official_title>Heart Failure and Early Stage Chronic Kidney Disease -Mineral Bone Disorder : the Importance of the New Biomarkers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pr. Semir Nouira</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Monastir</source>
  <brief_summary>
    <textblock>
      the objective of this study is to :&#xD;
&#xD;
      -Determinate wether the circulating levels of iFGF23 and klotho can be a predictor biomarker&#xD;
      of HF in patients with CKD-MBD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The disorders of mineral metabolism and bone disease are common complications in CKD patients&#xD;
      and they are associated with increased morbidity and mortality.&#xD;
&#xD;
      Abnormalities of the vasculature are seen in early CKD, producing vascular stiffness&#xD;
      contributing to left ventricular hypertrophy and its pathophysiology involves newly&#xD;
      discovered hormones, such as the fibroblast Growth factor 23 (FGF23) and α- klotho.&#xD;
&#xD;
      The FGF receptor and its co-receptor klotho moderate these effects. FGF23 levels inflate&#xD;
      early in in the advancement of CKD stage to attain levels in CKD stage 5D.&#xD;
&#xD;
      But we still have few knoweledges if these markers can have some drawbacks for predicting CVD&#xD;
      in early stage CKD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2015</start_date>
  <completion_date type="Actual">December 30, 2015</completion_date>
  <primary_completion_date type="Actual">September 30, 2015</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>Fibroblast Growth Factor 23 (FGF23)</measure>
    <time_frame>completed data base (after 4 months)</time_frame>
    <description>compare the circulating levels of FGF23 (pg/ml) in the two groups .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alpha Klotho</measure>
    <time_frame>completed data base (after 4 months)</time_frame>
    <description>compare the circulating levels of klotho (ng/ml) in the two groups .</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">111</enrollment>
  <condition>Kidney Disease, Chronic</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Heart Failure (HF)</arm_group_label>
    <description>subjects with a Left Ventricular Ejection Fraction (LVEF) &lt;50% or LVEF &gt;50% and E/e'&gt;10.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Heart Failure (NHF)</arm_group_label>
    <description>subjects with LVEF&gt;50%</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples were centrifuged, the plasma were collected and stored at -80°C until&#xD;
      utilization.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        subjects who visited the emmergency departement or the nephrology departement , meeting the&#xD;
        criteria inclusion and have given a written consent .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Early CKD stage&#xD;
&#xD;
          -  Heart failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infections&#xD;
&#xD;
          -  cancer&#xD;
&#xD;
          -  corticoid therapy&#xD;
&#xD;
          -  renal replacement therapy&#xD;
&#xD;
          -  Advanced CKD stage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lamti Feten, PhD student</last_name>
    <role>Study Chair</role>
    <affiliation>Research Laboratory (LR12SP18) University of Monastir Tunisia, Tunisia and Research Unit (UR17ES29) Faculty of Pharmacy , Monastir</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Monastir</investigator_affiliation>
    <investigator_full_name>Pr. Semir Nouira</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>FGF23</keyword>
  <keyword>klotho</keyword>
  <keyword>Mineral Bone Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Heart Failure</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/NCT03307707
org study id: CKD-MBD-HF
nct id: NCT03307707
lead sponsor: 
the objective of this study is to :

      -Determinate wether the circulating levels of iFGF23 and klotho can be a predictor biomarker
      of HF in patients with CKD-MBD.
The disorders of mineral metabolism and bone disease are common complications in CKD patients
      and they are associated with increased morbidity and mortality.

      Abnormalities of the vasculature are seen in early CKD, producing vascular stiffness
      contributing to left ventricular hypertrophy and its pathophysiology involves newly
      discovered hormones, such as the fibroblast Growth factor 23 (FGF23) and α- klotho.

      The FGF receptor and its co-receptor klotho moderate these effects. FGF23 levels inflate
      early in in the advancement of CKD stage to attain levels in CKD stage 5D.

      But we still have few knoweledges if these markers can have some drawbacks for predicting CVD
      in early stage CKD.
observational model: Cohort
time perspective: Prospective
measure: Fibroblast Growth Factor 23 (FGF23)
time frame: completed data base (after 4 months)
description: compare the circulating levels of FGF23 (pg/ml) in the two groups .
measure: Alpha Klotho
time frame: completed data base (after 4 months)
description: compare the circulating levels of klotho (ng/ml) in the two groups .
arm group label: Heart Failure (HF)
description: subjects with a Left Ventricular Ejection Fraction (LVEF) <50% or LVEF >50% and E/e'>10.
arm group label: No Heart Failure (NHF)
description: subjects with LVEF>50%
Blood samples were centrifuged, the plasma were collected and stored at -80°C until
      utilization.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lamti Feten, PhD student
role: Study Chair
affiliation: Research Laboratory (LR12SP18) University of Monastir Tunisia, Tunisia and Research Unit (UR17ES29) Faculty of Pharmacy , Monastir
responsible party type: Sponsor-Investigator
investigator affiliation: University of Monastir
investigator full name: Pr. Semir Nouira
investigator title: Professor
mesh term: Bone Diseases
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Heart Failure