<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/NCT03246204</url>
  </required_header>
  <id_info>
    <org_study_id>2015BAI12B06</org_study_id>
    <nct_id>NCT03246204</nct_id>
  </id_info>
  <brief_title>Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)</brief_title>
  <official_title>Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hebei Medical University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Renmin Hospital of Wuhan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is an observational, multicenter, prospective cohort study aimed at evaluating a&#xD;
      5-year screening programme for chronic kidney disease(CKD) in a population of elderly&#xD;
      patients, aged 65 years or more, in China.To analyze the etiology and composition spectrum,&#xD;
      the incidence of complications and co-morbidities.To assess the correlation between daily&#xD;
      living ability, mental and physical function, quality of life, nutritional status and&#xD;
      prognosis.To develop biomarkers of renal aging.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">February 2023</completion_date>
  <primary_completion_date type="Anticipated">February 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>5 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of End Stage Renal Disease (ESRD)</measure>
    <time_frame>5 year</time_frame>
    <description>ESRD will be defined as estimated glomerular filtration rate(eGFR)&lt;15 mL/min/1.73 m2 or dialysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>eGFR decline≥40%</measure>
    <time_frame>5 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute coronary syndrome</measure>
    <time_frame>5 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart failure</measure>
    <time_frame>5 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral stroke</measure>
    <time_frame>5 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral arterial disease</measure>
    <time_frame>5 year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum, whole blood，urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        subjects with 65 years or older&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age≥65 years&#xD;
&#xD;
          -  clinical diagnosis of CKD&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects who have a poor compliance and cannot be scheduled for follow-up&#xD;
&#xD;
          -  subjects participating in other interventional clinical trials&#xD;
&#xD;
          -  ESRD or dialysis&#xD;
&#xD;
          -  Acute kidney injury(AKI)&#xD;
&#xD;
          -  history of solid organ or bone marrow transplantation&#xD;
&#xD;
          -  active malignancy within 24 months prior to screening or metastatic cancer&#xD;
&#xD;
          -  life expectancy less than 6 months；&#xD;
&#xD;
          -  severe cognitive impairment（NYHA III or IV）&#xD;
&#xD;
          -  HIV infection or AIDS&#xD;
&#xD;
          -  subjects cannot be able to complete the assessment including dementia or other mental&#xD;
             disorders, limited physical activity, severe visual impairment&#xD;
&#xD;
          -  simple hematuria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>xiangmei chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>guangyan cai</last_name>
    <phone>00861066935462</phone>
    <email>caiguangyan@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>shuang liang</last_name>
    <phone>008615110246423</phone>
    <email>liangshuang301@163.com</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Chen Xiangmei</investigator_full_name>
    <investigator_title>Academician of Chinese Academy of Engineering</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03246204
org study id: 2015BAI12B06
nct id: NCT03246204
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The study is an observational, multicenter, prospective cohort study aimed at evaluating a
      5-year screening programme for chronic kidney disease(CKD) in a population of elderly
      patients, aged 65 years or more, in China.To analyze the etiology and composition spectrum,
      the incidence of complications and co-morbidities.To assess the correlation between daily
      living ability, mental and physical function, quality of life, nutritional status and
      prognosis.To develop biomarkers of renal aging.
observational model: Cohort
time perspective: Prospective
measure: Death
time frame: 5 year
measure: Incidence of End Stage Renal Disease (ESRD)
time frame: 5 year
description: ESRD will be defined as estimated glomerular filtration rate(eGFR)<15 mL/min/1.73 m2 or dialysis
measure: eGFR decline≥40%
time frame: 5 year
measure: Acute coronary syndrome
time frame: 5 year
measure: Heart failure
time frame: 5 year
measure: Cerebral stroke
time frame: 5 year
measure: Peripheral arterial disease
time frame: 5 year
serum, whole blood，urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: xiangmei chen
role: Principal Investigator
affiliation: Chinese PLA General Hospital
last name: guangyan cai
phone: 00861066935462
email: caiguangyan@sina.com
last name: shuang liang
phone: 008615110246423
email: liangshuang301@163.com
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Chen Xiangmei
investigator title: Academician of Chinese Academy of Engineering
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No