<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/NCT03246191</url>
  </required_header>
  <id_info>
    <org_study_id>2015BAI12B06-2</org_study_id>
    <nct_id>NCT03246191</nct_id>
  </id_info>
  <brief_title>Screening and Assessing the Risk Factors and Complications of Chronic Kidney Disease</brief_title>
  <official_title>Screening and Assessing the Risk Factors and Complications of Chronic Kidney Disease：a Cross - Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General 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>
      The study is an observational, cross-sectional study aimed at screening and accessing risk&#xD;
      factors and complications for Chinese chronic kidney disease (CKD) patients. To investigate&#xD;
      the prevalence of hypertension, cardiovascular and cerebrovascular diseases, protein energy&#xD;
      malnutrition（PEM）, cognitive impairment and other complications in the CKD patients. To&#xD;
      develop biomarkers of CKD.&#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">May 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of CKD complications</measure>
    <time_frame>baseline</time_frame>
    <description>hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition(PEM), cognitive impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomarkers of kidney function</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Genetic analyses</measure>
    <time_frame>baseline</time_frame>
    <description>circulating microRNA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire assessing cognitive function</measure>
    <time_frame>baseline</time_frame>
    <description>Montreal Cognitive Assessment-Basic Chinese Version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire assessing depression</measure>
    <time_frame>baseline</time_frame>
    <description>Beck Depression Inventory scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire assessing risk of malnutrition</measure>
    <time_frame>baseline</time_frame>
    <description>Malnutrition-Inflammation Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire assessing dietary intake</measure>
    <time_frame>baseline</time_frame>
    <description>Food Frequency Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire assessing quality of life</measure>
    <time_frame>baseline</time_frame>
    <description>Activity of daily living（ADL）and kidney disease quality of life （KDQOLTM-36）</description>
  </secondary_outcome>
  <enrollment type="Anticipated">900</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sample collection</intervention_name>
    <description>blood sample collection</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum, whole blood，urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        subjects with 18 years or older&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age≥18 years&#xD;
&#xD;
          -  clinical diagnosis of CKD&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End-stage renal disease(ESRD) or dialysis&#xD;
&#xD;
          -  Acute kidney injure(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;
          -  HIV infection or AIDS&#xD;
&#xD;
          -  acute inflammation&#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>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>wenling wang</last_name>
    <phone>008618600258258</phone>
    <email>wangwenlingczyy@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/NCT03246191
org study id: 2015BAI12B06-2
nct id: NCT03246191
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is an observational, cross-sectional study aimed at screening and accessing risk
      factors and complications for Chinese chronic kidney disease (CKD) patients. To investigate
      the prevalence of hypertension, cardiovascular and cerebrovascular diseases, protein energy
      malnutrition（PEM）, cognitive impairment and other complications in the CKD patients. To
      develop biomarkers of CKD.
observational model: Other
time perspective: Cross-Sectional
measure: Prevalence of CKD complications
time frame: baseline
description: hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition(PEM), cognitive impairment
measure: Biomarkers of kidney function
time frame: baseline
measure: Genetic analyses
time frame: baseline
description: circulating microRNA
measure: Questionnaire assessing cognitive function
time frame: baseline
description: Montreal Cognitive Assessment-Basic Chinese Version
measure: Questionnaire assessing depression
time frame: baseline
description: Beck Depression Inventory scores
measure: Questionnaire assessing risk of malnutrition
time frame: baseline
description: Malnutrition-Inflammation Score
measure: Questionnaire assessing dietary intake
time frame: baseline
description: Food Frequency Questionnaire
measure: Questionnaire assessing quality of life
time frame: baseline
description: Activity of daily living（ADL）and kidney disease quality of life （KDQOLTM-36）
intervention type: Other
intervention name: blood sample collection
description: blood sample collection
serum, whole blood，urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 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: wenling wang
phone: 008618600258258
email: wangwenlingczyy@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