<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/NCT02190318</url>
  </required_header>
  <id_info>
    <org_study_id>CHN-RENAL-IIS-2013-029</org_study_id>
    <nct_id>NCT02190318</nct_id>
  </id_info>
  <brief_title>Residual Renal Function Preservation in Peritoneal Dialysis Patients</brief_title>
  <official_title>The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Xiangya Hospital of Central South University</source>
  <brief_summary>
    <textblock>
      Aldosterone blockade is useful in preserving residual renal function in patients on PD.The&#xD;
      long term efficacy of dual blockade of the RAAS is better than monotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Residual renal function has been proven to contribute to improved survival and quality of&#xD;
      life of dialysis patients. It is now recognized as an important factor in the prognosis of&#xD;
      PD.The RAAS system is involved in the development of renal diseases. Angiotensin II and&#xD;
      aldosterone are vital in this process. The beneficial effect of angiotensin-converting enzyme&#xD;
      inhibitor or angiotensin receptor blocker on residual renal function has been demonstrated in&#xD;
      peritoneal dialysis patients. Unfortunately, neither ACE inhibition nor angiotensin receptor&#xD;
      blocker fully supprsses aldosterone production. Now much focus has been placed on aldosterone&#xD;
      antagonist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>residual renal function of peritoneal dialysis patients</measure>
    <time_frame>From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>peritoneal membrane function</measure>
    <time_frame>From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.</time_frame>
    <description>peritoneal membrane function is measured by peritoneal equilibration test to test the type of peritoneal transport. Briefly, a standard 4-hour dwell period was used (first exchange of the day), using a 2.5% glucose concentration 2-L volume exchange. The patient used their usual overnight dialysis regimen, and both the overnight and test drainage volumes were measured.The dialysate:plasma ratio of creatinine at the completion of the 4-hour dwell period (D/Pcreat) was used as the estimate of low-molecular-weight solute transport.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Chronic Renal Disease</condition>
  <arm_group>
    <arm_group_label>Losartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Losartan is taken orally 100mg/d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>spirolactone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>spirolactone is taken orally 20mg/d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>losartan in combination with spirolactone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>blank control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>patients with antihypertensives besides ACEI/ARBs and spirolactone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Losartan</intervention_name>
    <arm_group_label>Losartan</arm_group_label>
    <arm_group_label>losartan in combination with spirolactone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>spirolactone</intervention_name>
    <arm_group_label>losartan in combination with spirolactone</arm_group_label>
    <arm_group_label>spirolactone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blank control</intervention_name>
    <arm_group_label>blank control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who having been on PD continuously for one month, urine volume&gt;600 ml/d,&#xD;
             residual renal function&gt;2ml/min/1.73m2, blood pressure&gt;120/70mmHg, serum potassium&#xD;
             levels&lt;5.5mmol/l, stable clinical condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with infectious systemic disease, peritonitis during the preceding 1 month,&#xD;
             who had taken ACEI/ARBs in the 3 preceding months, spirolactone in the 2 preceding&#xD;
             weeks, intolerance to ACEI/ARBs, CHF, MI, malignant hypertension and stroke within the&#xD;
             preceding 6 months.&#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_contact>
    <last_name>Hong Liu, MD,phD</last_name>
    <phone>86-0731-85292057</phone>
    <email>liuh0618@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Liu, MD,phD</last_name>
      <phone>86-0731-85292057</phone>
      <email>liuh0618@163.com</email>
    </contact>
    <investigator>
      <last_name>Hong Liu, MD,phD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 31, 2014</last_update_submitted>
  <last_update_submitted_qc>July 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Second Xiangya Hospital of Central South University</investigator_affiliation>
    <investigator_full_name>Hong Liu</investigator_full_name>
    <investigator_title>deputy director of nephrology department</investigator_title>
  </responsible_party>
  <keyword>peritoneal dialysis；</keyword>
  <keyword>residual renal function；</keyword>
  <keyword>RAAS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Losartan</mesh_term>
    <mesh_term>Spironolactone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02190318
org study id: CHN-RENAL-IIS-2013-029
nct id: NCT02190318
lead sponsor: 
collaborator: 
Aldosterone blockade is useful in preserving residual renal function in patients on PD.The
      long term efficacy of dual blockade of the RAAS is better than monotherapy.
Residual renal function has been proven to contribute to improved survival and quality of
      life of dialysis patients. It is now recognized as an important factor in the prognosis of
      PD.The RAAS system is involved in the development of renal diseases. Angiotensin II and
      aldosterone are vital in this process. The beneficial effect of angiotensin-converting enzyme
      inhibitor or angiotensin receptor blocker on residual renal function has been demonstrated in
      peritoneal dialysis patients. Unfortunately, neither ACE inhibition nor angiotensin receptor
      blocker fully supprsses aldosterone production. Now much focus has been placed on aldosterone
      antagonist.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: residual renal function of peritoneal dialysis patients
time frame: From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.
measure: peritoneal membrane function
time frame: From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.
description: peritoneal membrane function is measured by peritoneal equilibration test to test the type of peritoneal transport. Briefly, a standard 4-hour dwell period was used (first exchange of the day), using a 2.5% glucose concentration 2-L volume exchange. The patient used their usual overnight dialysis regimen, and both the overnight and test drainage volumes were measured.The dialysate:plasma ratio of creatinine at the completion of the 4-hour dwell period (D/Pcreat) was used as the estimate of low-molecular-weight solute transport.
arm group label: Losartan
arm group type: Experimental
description: Losartan is taken orally 100mg/d
arm group label: spirolactone
arm group type: Experimental
description: spirolactone is taken orally 20mg/d
arm group label: losartan in combination with spirolactone
arm group type: Experimental
description: Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d
arm group label: blank control
arm group type: Sham Comparator
description: patients with antihypertensives besides ACEI/ARBs and spirolactone.
intervention type: Drug
intervention name: Losartan
arm group label: Losartan
arm group label: losartan in combination with spirolactone
intervention type: Drug
intervention name: spirolactone
arm group label: losartan in combination with spirolactone
arm group label: spirolactone
intervention type: Other
intervention name: blank control
arm group label: blank control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hong Liu, MD,phD
phone: 86-0731-85292057
email: liuh0618@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Second Xiangya Hospital of Central South University
investigator full name: Hong Liu
investigator title: deputy director of nephrology department
mesh term: Renal Insufficiency, Chronic
mesh term: Kidney Failure, Chronic
mesh term: Losartan
mesh term: Spironolactone