<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/NCT03007160</url>
  </required_header>
  <id_info>
    <org_study_id>DAWNRAYS101</org_study_id>
    <nct_id>NCT03007160</nct_id>
  </id_info>
  <brief_title>A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence</brief_title>
  <official_title>A Randomized, Blank Controlled, Multicenter Clinical Trial of the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dawnrays Pharmaceutical (Holdings) Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dawnrays Pharmaceutical (Holdings) Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis&#xD;
      formation or recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study takes &quot;Rate of stone recurrence&quot; as primary outcome measure, by random, blank&#xD;
      control, and multicenter clinical trial design method, assess the efficacy and safety of&#xD;
      potassium citrate extended-release tablets on Urolithiasis formation or recurrence, provide&#xD;
      evidence for drug re-registration, and observe its efficacy on Urinary calculi such as renal&#xD;
      tubular acidosis with calcium stone, and uric acid stones with or without calcium stone,&#xD;
      urinary tract stone of effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Urolithiasis recurrence</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time of stone recurrence</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changes of urine citric acid content compared with baseline</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changes of Urine pH value compared with baseline</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2001</enrollment>
  <condition>Urolithiasis</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Potassium Citrate Extended-release Tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blank control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects do not take the investigational product</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Potassium Citrate Extended-release Tablets</intervention_name>
    <description>Daily 3.24g, Po ,Tid, each 1.08g/tablets</description>
    <arm_group_label>Experimental group</arm_group_label>
    <other_name>Juyuansuanjia Huanshi Pian</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with upper urinary tract calculi surgery and/or ESWL within 3 months；&#xD;
&#xD;
          -  Stone free or had residual stone fragments with a less than 4 mm diamete；&#xD;
&#xD;
          -  18-70 years of age; the gender is not limited；&#xD;
&#xD;
          -  Agree to take effective contraceptive measures during the study period, and female of&#xD;
             childbearing age whose pregnancy test is negative；&#xD;
&#xD;
          -  Subjects with no mental illness and language dysfunction, can understand the situation&#xD;
             of the study and have signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with infectious stones, medical stones and urinary tract obstruction；&#xD;
&#xD;
          -  Patients with hyperkalemia (K+&gt;5.5mmol/L) (or patients with factors or disease that&#xD;
             can cause hyperkalemia), because the further increase in blood potassium can lead to&#xD;
             cardiac arrest. These factors include disease or strenuous exercise, chronic renal&#xD;
             failure, uncontrolled diabetes, acute dehydration, excessive, adrenal insufficiency,&#xD;
             extensive tissue failure. Patients who takes potassium sparing diuretics (such as&#xD;
             triamterene, spironolactone, amiloride)；&#xD;
&#xD;
          -  Patients with gastrointestinal disorders, such as peptic ulcer, severe vomiting,&#xD;
             diarrhea, delayed gastric emptying, intestinal obstruction, etc.；&#xD;
&#xD;
          -  Combined with cardiovascular, liver, kidney, hematopoietic system, such as severe&#xD;
             primary disease, or known to affect the survival of serious diseases (such as cancer&#xD;
             or AIDS), or patients with with disabilities mentally or legally；&#xD;
&#xD;
          -  Patients with renal insufficiency (1.2 times the upper limit of the normal value of&#xD;
             serum creatinine and urea nitrogen)；&#xD;
&#xD;
          -  The recent (within 6 months) with family planners；&#xD;
&#xD;
          -  Allergic to this product；&#xD;
&#xD;
          -  To participate in other clinical trials in the past three months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhangqun YE, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhangqun YE, M.D.</last_name>
    <phone>(+86)13507191761</phone>
    <email>zhangqun_ye@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Fifth Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dehui LAI</last_name>
      <phone>(+86)13570508863</phone>
      <email>dehuilai@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Yongzhong HE</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dehui LAI</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Changwei LIU</last_name>
      <phone>(+86)13526709425</phone>
      <email>lcw8001@126.com</email>
    </contact>
    <investigator>
      <last_name>Changbao XU</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Changwei LIU</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaolin GUO, M.D.</last_name>
      <phone>(+86)13886042051</phone>
      <email>guoxiaolin0488@sina.com</email>
    </contact>
    <investigator>
      <last_name>Zhangqun YE, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xiaolin GUO, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wuhan No.1 Hospital（Wuhan Integrated TCM &amp; Western Medicine Hospital）</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mingxi XU</last_name>
      <phone>(+86)18221683312</phone>
      <email>xuhuaneric@126.com</email>
    </contact>
    <investigator>
      <last_name>Zhong WANG</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mingxi XU</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhejiang Xiaoshan Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xing WANG</last_name>
      <phone>(+86)18058806706</phone>
      <email>fly115135@sohu.com</email>
    </contact>
    <investigator>
      <last_name>Yi FAN</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xing WANG</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sfoungaristos S, Gofrit ON, Yutkin V, Pode D, Duvdevani M. Prevention of renal stone disease recurrence. A systematic review of contemporary pharmaceutical options. Expert Opin Pharmacother. 2015 Jun;16(8):1209-18. doi: 10.1517/14656566.2015.1037740. Epub 2015 Apr 16.</citation>
    <PMID>25881654</PMID>
  </reference>
  <reference>
    <citation>Soygur T, Akbay A, Kupeli S. Effect of potassium citrate therapy on stone recurrence and residual fragments after shockwave lithotripsy in lower caliceal calcium oxalate urolithiasis: a randomized controlled trial. J Endourol. 2002 Apr;16(3):149-52. doi: 10.1089/089277902753716098.</citation>
    <PMID>12028622</PMID>
  </reference>
  <reference>
    <citation>Lee YH, Huang WC, Tsai JY, Huang JK. The efficacy of potassium citrate based medical prophylaxis for preventing upper urinary tract calculi: a midterm followup study. J Urol. 1999 May;161(5):1453-7.</citation>
    <PMID>10210371</PMID>
  </reference>
  <reference>
    <citation>Fabris A, Lupo A, Bernich P, Abaterusso C, Marchionna N, Nouvenne A, Gambaro G. Long-term treatment with potassium citrate and renal stones in medullary sponge kidney. Clin J Am Soc Nephrol. 2010 Sep;5(9):1663-8. doi: 10.2215/CJN.00220110. Epub 2010 Jun 24.</citation>
    <PMID>20576821</PMID>
  </reference>
  <reference>
    <citation>Bartoletti R, Cai T, Mondaini N, Melone F, Travaglini F, Carini M, Rizzo M. Epidemiology and risk factors in urolithiasis. Urol Int. 2007;79 Suppl 1:3-7. doi: 10.1159/000104434.</citation>
    <PMID>17726345</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>January 31, 2018</last_update_submitted>
  <last_update_submitted_qc>January 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Urinary Calculi</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Potassium Citrate</mesh_term>
  </intervention_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/NCT03007160
org study id: DAWNRAYS101
nct id: NCT03007160
lead sponsor: 
has dmc: No
Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis
      formation or recurrence.
This study takes "Rate of stone recurrence" as primary outcome measure, by random, blank
      control, and multicenter clinical trial design method, assess the efficacy and safety of
      potassium citrate extended-release tablets on Urolithiasis formation or recurrence, provide
      evidence for drug re-registration, and observe its efficacy on Urinary calculi such as renal
      tubular acidosis with calcium stone, and uric acid stones with or without calcium stone,
      urinary tract stone of effectiveness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Rate of Urolithiasis recurrence
time frame: through study completion, an average of 1 year
measure: Time of stone recurrence
time frame: through study completion, an average of 1 year
measure: The changes of urine citric acid content compared with baseline
time frame: through study completion, an average of 1 year
measure: The changes of Urine pH value compared with baseline
time frame: through study completion, an average of 1 year
arm group label: Experimental group
arm group type: Experimental
description: Potassium Citrate Extended-release Tablets
arm group label: Blank control group
arm group type: No Intervention
description: Subjects do not take the investigational product
intervention type: Drug
intervention name: Potassium Citrate Extended-release Tablets
description: Daily 3.24g, Po ,Tid, each 1.08g/tablets
arm group label: Experimental group
other name: Juyuansuanjia Huanshi Pian
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Zhangqun YE, M.D.
role: Principal Investigator
affiliation: Tongji Hospital
last name: Zhangqun YE, M.D.
phone: (+86)13507191761
email: zhangqun_ye@163.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
citation: Sfoungaristos S, Gofrit ON, Yutkin V, Pode D, Duvdevani M. Prevention of renal stone disease recurrence. A systematic review of contemporary pharmaceutical options. Expert Opin Pharmacother. 2015 Jun;16(8):1209-18. doi: 10.1517/14656566.2015.1037740. Epub 2015 Apr 16.
PMID: 25881654
citation: Soygur T, Akbay A, Kupeli S. Effect of potassium citrate therapy on stone recurrence and residual fragments after shockwave lithotripsy in lower caliceal calcium oxalate urolithiasis: a randomized controlled trial. J Endourol. 2002 Apr;16(3):149-52. doi: 10.1089/089277902753716098.
PMID: 12028622
citation: Lee YH, Huang WC, Tsai JY, Huang JK. The efficacy of potassium citrate based medical prophylaxis for preventing upper urinary tract calculi: a midterm followup study. J Urol. 1999 May;161(5):1453-7.
PMID: 10210371
citation: Fabris A, Lupo A, Bernich P, Abaterusso C, Marchionna N, Nouvenne A, Gambaro G. Long-term treatment with potassium citrate and renal stones in medullary sponge kidney. Clin J Am Soc Nephrol. 2010 Sep;5(9):1663-8. doi: 10.2215/CJN.00220110. Epub 2010 Jun 24.
PMID: 20576821
citation: Bartoletti R, Cai T, Mondaini N, Melone F, Travaglini F, Carini M, Rizzo M. Epidemiology and risk factors in urolithiasis. Urol Int. 2007;79 Suppl 1:3-7. doi: 10.1159/000104434.
PMID: 17726345
responsible party type: Sponsor
mesh term: Urolithiasis
mesh term: Urinary Calculi
mesh term: Recurrence
mesh term: Potassium Citrate
sharing ipd: No