<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/NCT03261154</url>
  </required_header>
  <id_info>
    <org_study_id>2016-P2-126-01</org_study_id>
    <nct_id>NCT03261154</nct_id>
  </id_info>
  <brief_title>Serum iPTH, Calcium and Phosphate, and the Risk of Mortality in Beijing Elderly Hemodialysis Population</brief_title>
  <official_title>Serum iPTH, Calcium and Phosphate, and the Risk of Mortality in Beijing Elderly Hemodialysis Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenhu Liu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Friendship Hospital</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>
      Incidence of End Stage Renal Disease (ESRD) amongst elderly patient group is continuously&#xD;
      increasing with population aging progressing. Mineral and bone disorder (MBD) is a common&#xD;
      complication caused by ESRD, it raises the incidence of cardiovascular disease (CVD) in&#xD;
      hemodialysis patients, as well as mortality.&#xD;
&#xD;
      Joint effects of Kidney failure and aging on elderly hemodialysis patients make the&#xD;
      contribution factors of CKD-MBD quite complex, and it also leads to differences in clinic&#xD;
      manifestation between elderly hemodialysis patients and non-elderly hemodialysis patients.&#xD;
      Since not much studies had been done for this specific subject, thus, research on elderly&#xD;
      patients who is taking Maintenance hemodialysis is very necessary. This study is a&#xD;
      retrospective research to identify optimized target value of Calcium and Phosphorus for&#xD;
      elderly patients taking maintenance hemodialysis and hence provide guidance for clinical&#xD;
      practices. The data for this study will be provided by Beijing Blood Purification Quality&#xD;
      Control and Improvement Center. Clinical files and Calcium and Phosphorus metabolic indices&#xD;
      will be collected amongst elderly patients who were elder than 65 years and was taking&#xD;
      maintenance hemodialysis between Jan 1st, 2012 through Dec 31st, 2016. Relationship between&#xD;
      Calcium level, Phosphorus level, iPTH index, all-cause mortality and CVD caused mortality&#xD;
      will be analyzed to identify optimized range of target Calcium levels, Phosphorus level for&#xD;
      hemodialysis treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>5 years</time_frame>
    <description>all patients died in our observation period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CVD-related mortality</measure>
    <time_frame>5 years</time_frame>
    <description>the cause of death was cardiovascular disease related</description>
  </secondary_outcome>
  <enrollment type="Actual">1000</enrollment>
  <condition>End Stage Renal Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        the data for this study will be provided by Beijing Blood Purification Quality Control and&#xD;
        Improvement Center. Clinical files and Calcium and Phosphorus metabolic indices will be&#xD;
        collected amongst elderly patients who were elder than 65 years and was taking maintenance&#xD;
        hemodialysis between Jan 1st, 2012 through Dec 31st, 2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The data shall include the information of elderly hemodialysis patients who were 65&#xD;
             years or elder between Jan 1st, 2012 and Dec 31st, 2016&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients who only has less than 6 months history of hemodialysis since selected in&#xD;
             the research patient group The patients who passed away within 3 months since selected&#xD;
             in the research patient group The patients who took less than 3 hemodialysis in a week&#xD;
             The patients who took kidney transplant during the research time period The patients&#xD;
             who do not have blood biochemical results in the records&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Friendship hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Wenhu Liu</investigator_full_name>
    <investigator_title>Director of Nephrology Deptartment, Beijing FH</investigator_title>
  </responsible_party>
  <keyword>Serum iPTH</keyword>
  <keyword>Calcium</keyword>
  <keyword>Phosphate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</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/NCT03261154
org study id: 2016-P2-126-01
nct id: NCT03261154
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Incidence of End Stage Renal Disease (ESRD) amongst elderly patient group is continuously
      increasing with population aging progressing. Mineral and bone disorder (MBD) is a common
      complication caused by ESRD, it raises the incidence of cardiovascular disease (CVD) in
      hemodialysis patients, as well as mortality.

      Joint effects of Kidney failure and aging on elderly hemodialysis patients make the
      contribution factors of CKD-MBD quite complex, and it also leads to differences in clinic
      manifestation between elderly hemodialysis patients and non-elderly hemodialysis patients.
      Since not much studies had been done for this specific subject, thus, research on elderly
      patients who is taking Maintenance hemodialysis is very necessary. This study is a
      retrospective research to identify optimized target value of Calcium and Phosphorus for
      elderly patients taking maintenance hemodialysis and hence provide guidance for clinical
      practices. The data for this study will be provided by Beijing Blood Purification Quality
      Control and Improvement Center. Clinical files and Calcium and Phosphorus metabolic indices
      will be collected amongst elderly patients who were elder than 65 years and was taking
      maintenance hemodialysis between Jan 1st, 2012 through Dec 31st, 2016. Relationship between
      Calcium level, Phosphorus level, iPTH index, all-cause mortality and CVD caused mortality
      will be analyzed to identify optimized range of target Calcium levels, Phosphorus level for
      hemodialysis treatment
observational model: Case-Only
time perspective: Retrospective
measure: All-cause mortality
time frame: 5 years
description: all patients died in our observation period
measure: CVD-related mortality
time frame: 5 years
description: the cause of death was cardiovascular disease related
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Wenhu Liu
investigator title: Director of Nephrology Deptartment, Beijing FH
mesh term: Kidney Failure, Chronic