<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/NCT04399915</url>
  </required_header>
  <id_info>
    <org_study_id>0119U000002</org_study_id>
    <nct_id>NCT04399915</nct_id>
  </id_info>
  <brief_title>Effect of Oxalate and Urate Metabolism on CKD Evolution</brief_title>
  <official_title>Effect of Oxalate and Urate Metabolism on the Evolution of Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Institute of Nephrology of the Academy of Medical Sciences of Ukraine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Institute of Nephrology of the Academy of Medical Sciences of Ukraine</source>
  <oversight_info>
    <has_dmc>Yes</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 current study primarily aimed to characterize the oxalate and uric acid metabolism in CKD&#xD;
      patients and to analyze its association with renal survival prognosis. Secondarily, the study&#xD;
      is planned to determine whether hyperoxalemia and hyperuricemia are independent risk factors&#xD;
      for cardiovascular events and mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study protocol is approved by a local Ethics Committee and registered in Domestic&#xD;
      Clinical Trial Registry (Identifier 0119U000002). Writing informed consent is obtained from&#xD;
      all subjects participating in the study.&#xD;
&#xD;
      The study will enroll 300 participants (250 CKD patients at stage 1-5 and 50 healthy&#xD;
      subjects). Routine biochemical parameters including blood and daily dialysate concentration&#xD;
      of urea and creatinine, serum albumin, C-reactive protein (CRP), glucose, electrolytes, and&#xD;
      lipid profile parameters will carry out. Total oxalate-degrading activity in fecal samples,&#xD;
      as well as plasma oxalic acid concentration, daily urinary oxalate excretion and peritoneal&#xD;
      dialysis effluent oxalate concentration (if any) will determine. Uric acid will also measure&#xD;
      in serum, urine and dialysate of peritoneal dialysis patients.&#xD;
&#xD;
      The study will be followed up for 3 years. The primary endpoint is cardiovascular events,&#xD;
      secondary endpoints are dialysis adequacy and all-cause mortality. All the endpoints will be&#xD;
      collected, as well as other outcomes, such as chronic inflammation, dyslipidemia and dialysis&#xD;
      dose, and so on. The outcomes will be analyzed using statistical software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Renal Survival for CKD stages 1-3</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardio-vascular Events</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>CKD</condition>
  <condition>ESRD</condition>
  <condition>Hyperuricemia</condition>
  <condition>Oxaluria</condition>
  <arm_group>
    <arm_group_label>Hyperoxalemia/Hyperuricemia Group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyperoxalemia/Hyperuricemia-free Group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Subjects</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        CKD stage 1-5 patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years old,&#xD;
&#xD;
          -  CKD stage 1-4,&#xD;
&#xD;
          -  the patients did not take antibiotics and/or probiotics, lipid- and/or urate-lowering&#xD;
             therapy for at least past 3 months or:&#xD;
&#xD;
          -  dialysis treatment for at least 3 months,&#xD;
&#xD;
          -  a stable clinical condition and adequately functioning arteriovenous fistula or&#xD;
             peritoneal access,&#xD;
&#xD;
          -  a target level of Kt/V (≥ 1.4 for the HD patients and ≥1.7 for the PD patients).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hospitalization in the preceding 3 months,&#xD;
&#xD;
          -  previous history or actual diagnosis of peritonitis, anemia, systemic and malignant&#xD;
             diseases, acute inflammation processes, immunosuppressive treatment and active&#xD;
             hepatitis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Natalia Stepanova</name>
      <address>
        <city>Kyiv</city>
        <zip>04050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalia Stepanova, Dr.Sc.</last_name>
      <phone>+380442259377</phone>
      <email>nmstep88@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Ukraine</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>May 19, 2020</last_update_submitted>
  <last_update_submitted_qc>May 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CKD</keyword>
  <keyword>hemodialysis</keyword>
  <keyword>peritoneal dialysis</keyword>
  <keyword>oxalate</keyword>
  <keyword>uric acid</keyword>
  <keyword>metabolism</keyword>
  <keyword>renal survival</keyword>
  <keyword>cardio-vascular events</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperuricemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04399915
org study id: 0119U000002
nct id: NCT04399915
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The current study primarily aimed to characterize the oxalate and uric acid metabolism in CKD
      patients and to analyze its association with renal survival prognosis. Secondarily, the study
      is planned to determine whether hyperoxalemia and hyperuricemia are independent risk factors
      for cardiovascular events and mortality.
The study protocol is approved by a local Ethics Committee and registered in Domestic
      Clinical Trial Registry (Identifier 0119U000002). Writing informed consent is obtained from
      all subjects participating in the study.

      The study will enroll 300 participants (250 CKD patients at stage 1-5 and 50 healthy
      subjects). Routine biochemical parameters including blood and daily dialysate concentration
      of urea and creatinine, serum albumin, C-reactive protein (CRP), glucose, electrolytes, and
      lipid profile parameters will carry out. Total oxalate-degrading activity in fecal samples,
      as well as plasma oxalic acid concentration, daily urinary oxalate excretion and peritoneal
      dialysis effluent oxalate concentration (if any) will determine. Uric acid will also measure
      in serum, urine and dialysate of peritoneal dialysis patients.

      The study will be followed up for 3 years. The primary endpoint is cardiovascular events,
      secondary endpoints are dialysis adequacy and all-cause mortality. All the endpoints will be
      collected, as well as other outcomes, such as chronic inflammation, dyslipidemia and dialysis
      dose, and so on. The outcomes will be analyzed using statistical software.
observational model: Case-Control
time perspective: Prospective
measure: Renal Survival for CKD stages 1-3
time frame: 3 years
measure: Cardio-vascular Events
time frame: 3 years
arm group label: Hyperoxalemia/Hyperuricemia Group
arm group label: Hyperoxalemia/Hyperuricemia-free Group
arm group label: Healthy Subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Ukraine
responsible party type: Sponsor
mesh term: Hyperuricemia
sharing ipd: Undecided