<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/NCT03010696</url>
  </required_header>
  <id_info>
    <org_study_id>CAUPCKD-01</org_study_id>
    <nct_id>NCT03010696</nct_id>
  </id_info>
  <brief_title>The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)</brief_title>
  <official_title>The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Agricultural University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University Aerospace Centre Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Chinese Armed Police Forces</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Anzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Shougang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Heyiyuan Biotech Co. Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen Microbiota Technology Co. Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>China Agricultural University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the differences of gut Microbiome/Metabolite&#xD;
      between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis&#xD;
      patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Microbiota-derived uremic toxin</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fecal Microbiome</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal metabolites</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood metabolites</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete blood count</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood biochemistry test</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">293</enrollment>
  <condition>Kidney Failure, Chronic</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <description>Normal kidney function</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESRD patients</arm_group_label>
    <description>Diagnosed as ESRD with hemodialysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No interventions, questionnaire, collect specimen</intervention_name>
    <arm_group_label>ESRD patients</arm_group_label>
    <arm_group_label>Healthy subjects</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood, serum, feces, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Two hundred and twenty three ESRD patients with hemodialysis are recruited from Department&#xD;
        of Nephrology of 4 hospitals. Seventy healthy subjects are also recruited to compare the&#xD;
        microbiome/metabolite differences between two groups.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For Healthy Subjects&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years old&#xD;
&#xD;
          -  Liver and kidney function is normal&#xD;
&#xD;
          -  18.5≤BMI≤29.9&#xD;
&#xD;
          -  Agree to sign the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed as Metabolic syndrome&#xD;
&#xD;
          -  Diagnosed as Cirrhosis&#xD;
&#xD;
          -  Diagnosed as kidney disease&#xD;
&#xD;
          -  Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic&#xD;
             products, etc.) within 14 days before the study&#xD;
&#xD;
          -  Taking antibiotics or antifungal drugs within 30 days before the study&#xD;
&#xD;
        For ESRD patients&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Age over 18 years old&#xD;
&#xD;
          -  Patients who diagnosed as ESRD with hemodialysis&#xD;
&#xD;
          -  Fixed hemodialysis cycle (average 3 times a week)&#xD;
&#xD;
          -  Agree to sign the informed consent form&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Taking antibiotics or antifungal drugs within 30 days before the study&#xD;
&#xD;
          -  Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic&#xD;
             products, etc.) within 14 days before the study&#xD;
&#xD;
          -  Reasercher are not sure whether the subjects are willing or able to complete the study&#xD;
&#xD;
          -  Subject participated in other research projects within two months before the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fazheng Ren, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>China Agricultural Universtiy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Chinese Armed Police Forces</name>
      <address>
        <city>Beijing</city>
        <zip>100039</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Aerospace Centre Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100049</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Shougang Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100144</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Vaziri ND, Wong J, Pahl M, Piceno YM, Yuan J, DeSantis TZ, Ni Z, Nguyen TH, Andersen GL. Chronic kidney disease alters intestinal microbial flora. Kidney Int. 2013 Feb;83(2):308-15. doi: 10.1038/ki.2012.345. Epub 2012 Sep 19.</citation>
    <PMID>22992469</PMID>
  </reference>
  <reference>
    <citation>Poesen R, Windey K, Neven E, Kuypers D, De Preter V, Augustijns P, D'Haese P, Evenepoel P, Verbeke K, Meijers B. The Influence of CKD on Colonic Microbial Metabolism. J Am Soc Nephrol. 2016 May;27(5):1389-99. doi: 10.1681/ASN.2015030279. Epub 2015 Sep 23.</citation>
    <PMID>26400570</PMID>
  </reference>
  <reference>
    <citation>Koppe L, Mafra D, Fouque D. Probiotics and chronic kidney disease. Kidney Int. 2015 Nov;88(5):958-66. doi: 10.1038/ki.2015.255. Epub 2015 Sep 16.</citation>
    <PMID>26376131</PMID>
  </reference>
  <reference>
    <citation>Anders HJ, Andersen K, Stecher B. The intestinal microbiota, a leaky gut, and abnormal immunity in kidney disease. Kidney Int. 2013 Jun;83(6):1010-6. doi: 10.1038/ki.2012.440. Epub 2013 Jan 16.</citation>
    <PMID>23325079</PMID>
  </reference>
  <reference>
    <citation>Ramezani A, Raj DS. The gut microbiome, kidney disease, and targeted interventions. J Am Soc Nephrol. 2014 Apr;25(4):657-70. doi: 10.1681/ASN.2013080905. Epub 2013 Nov 14.</citation>
    <PMID>24231662</PMID>
  </reference>
  <reference>
    <citation>Poesen R, Claes K, Evenepoel P, de Loor H, Augustijns P, Kuypers D, Meijers B. Microbiota-Derived Phenylacetylglutamine Associates with Overall Mortality and Cardiovascular Disease in Patients with CKD. J Am Soc Nephrol. 2016 Nov;27(11):3479-3487. doi: 10.1681/ASN.2015121302. Epub 2016 May 26.</citation>
    <PMID>27230658</PMID>
  </reference>
  <reference>
    <citation>Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available.</citation>
    <PMID>17898101</PMID>
  </reference>
  <reference>
    <citation>Aronov PA, Luo FJ, Plummer NS, Quan Z, Holmes S, Hostetter TH, Meyer TW. Colonic contribution to uremic solutes. J Am Soc Nephrol. 2011 Sep;22(9):1769-76. doi: 10.1681/ASN.2010121220. Epub 2011 Jul 22.</citation>
    <PMID>21784895</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>October 21, 2020</last_update_submitted>
  <last_update_submitted_qc>October 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Agricultural University</investigator_affiliation>
    <investigator_full_name>Fazheng Ren</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Kidney Failure, Chronic</keyword>
  <keyword>Uremic toxins</keyword>
  <keyword>Gastrointestinal Microbiome</keyword>
  <keyword>Metabolomics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</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/NCT03010696
org study id: CAUPCKD-01
nct id: NCT03010696
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to investigate the differences of gut Microbiome/Metabolite
      between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis
      patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Microbiota-derived uremic toxin
time frame: Through study completion, an average of 1 year
measure: Fecal Microbiome
time frame: Through study completion, an average of 1 year
measure: Fecal metabolites
time frame: Through study completion, an average of 1 year
measure: Blood metabolites
time frame: Through study completion, an average of 1 year
measure: Complete blood count
time frame: Through study completion, an average of 1 year
measure: Blood biochemistry test
time frame: Through study completion, an average of 1 year
arm group label: Healthy subjects
description: Normal kidney function
arm group label: ESRD patients
description: Diagnosed as ESRD with hemodialysis
intervention type: Other
intervention name: No interventions, questionnaire, collect specimen
arm group label: ESRD patients
arm group label: Healthy subjects
whole blood, serum, feces, urine
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fazheng Ren, PhD
role: Principal Investigator
affiliation: China Agricultural Universtiy
facility: 
facility: 
facility: 
facility: 
country: China
citation: Vaziri ND, Wong J, Pahl M, Piceno YM, Yuan J, DeSantis TZ, Ni Z, Nguyen TH, Andersen GL. Chronic kidney disease alters intestinal microbial flora. Kidney Int. 2013 Feb;83(2):308-15. doi: 10.1038/ki.2012.345. Epub 2012 Sep 19.
PMID: 22992469
citation: Poesen R, Windey K, Neven E, Kuypers D, De Preter V, Augustijns P, D'Haese P, Evenepoel P, Verbeke K, Meijers B. The Influence of CKD on Colonic Microbial Metabolism. J Am Soc Nephrol. 2016 May;27(5):1389-99. doi: 10.1681/ASN.2015030279. Epub 2015 Sep 23.
PMID: 26400570
citation: Koppe L, Mafra D, Fouque D. Probiotics and chronic kidney disease. Kidney Int. 2015 Nov;88(5):958-66. doi: 10.1038/ki.2015.255. Epub 2015 Sep 16.
PMID: 26376131
citation: Anders HJ, Andersen K, Stecher B. The intestinal microbiota, a leaky gut, and abnormal immunity in kidney disease. Kidney Int. 2013 Jun;83(6):1010-6. doi: 10.1038/ki.2012.440. Epub 2013 Jan 16.
PMID: 23325079
citation: Ramezani A, Raj DS. The gut microbiome, kidney disease, and targeted interventions. J Am Soc Nephrol. 2014 Apr;25(4):657-70. doi: 10.1681/ASN.2013080905. Epub 2013 Nov 14.
PMID: 24231662
citation: Poesen R, Claes K, Evenepoel P, de Loor H, Augustijns P, Kuypers D, Meijers B. Microbiota-Derived Phenylacetylglutamine Associates with Overall Mortality and Cardiovascular Disease in Patients with CKD. J Am Soc Nephrol. 2016 Nov;27(11):3479-3487. doi: 10.1681/ASN.2015121302. Epub 2016 May 26.
PMID: 27230658
citation: Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available.
PMID: 17898101
citation: Aronov PA, Luo FJ, Plummer NS, Quan Z, Holmes S, Hostetter TH, Meyer TW. Colonic contribution to uremic solutes. J Am Soc Nephrol. 2011 Sep;22(9):1769-76. doi: 10.1681/ASN.2010121220. Epub 2011 Jul 22.
PMID: 21784895
responsible party type: Principal Investigator
investigator affiliation: China Agricultural University
investigator full name: Fazheng Ren
investigator title: Professor
mesh term: Kidney Failure, Chronic
mesh term: Renal Insufficiency
sharing ipd: No