<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/NCT02199444</url>
  </required_header>
  <id_info>
    <org_study_id>P-C Sev</org_study_id>
    <nct_id>NCT02199444</nct_id>
  </id_info>
  <brief_title>Effect of Sevelamer on P-cresol Levels in CKD</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</source>
  <brief_summary>
    <textblock>
      The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by&#xD;
      resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease&#xD;
      (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly&#xD;
      demanded. It has been reported that the phosphate binder sevelamer sequesters p-cresol in&#xD;
      vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our&#xD;
      study was to evaluate the effect of sevelamer on p-cresol levels in CKD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <phase>Phase 3</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect on p-creol levels</measure>
    <time_frame>3 months</time_frame>
    <description>The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Chronic Kidney Disease Stage 3-5</condition>
  <arm_group>
    <arm_group_label>Sevelamer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The dose of Sev was 2400 mg (800 mg three times a day) in all patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The patients received placebo three times a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevelamer</intervention_name>
    <description>The dose of Sev was 2400 mg (800 mg three times a day) in all patients.</description>
    <arm_group_label>Sevelamer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years,&#xD;
&#xD;
          -  CKD stage 3-5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existing or previous treatment within the last 1 year with a phosphate binder;&#xD;
&#xD;
          -  hyperphosphatemia (&gt;5.6 mg/dL);&#xD;
&#xD;
          -  hypophosphatemia (&lt;2.5 mg/dL);&#xD;
&#xD;
          -  malnutrition,&#xD;
&#xD;
          -  malignant neoplasms,&#xD;
&#xD;
          -  current history of gastrointestinal and/or endocrine diseases.&#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>eleonora riccio, md</last_name>
    <phone>3396770124</phone>
    <email>elyriccio@libero.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>federico II university, department of nephrology</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>eleonora riccio, md</last_name>
      <phone>3396770124</phone>
      <email>elyriccio@libero.it</email>
    </contact>
    <investigator>
      <last_name>eleonora riccio, md</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>February 17, 2015</last_update_submitted>
  <last_update_submitted_qc>February 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Eleonora Riccio</investigator_full_name>
    <investigator_title>MD</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sevelamer</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/NCT02199444
org study id: P-C Sev
nct id: NCT02199444
lead sponsor: 
The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by
      resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease
      (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly
      demanded. It has been reported that the phosphate binder sevelamer sequesters p-cresol in
      vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our
      study was to evaluate the effect of sevelamer on p-cresol levels in CKD patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Effect on p-creol levels
time frame: 3 months
description: The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy.
arm group label: Sevelamer
arm group type: Experimental
description: The dose of Sev was 2400 mg (800 mg three times a day) in all patients.
arm group label: Placebo
arm group type: Placebo Comparator
description: The patients received placebo three times a day
intervention type: Drug
intervention name: Sevelamer
description: The dose of Sev was 2400 mg (800 mg three times a day) in all patients.
arm group label: Sevelamer
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: eleonora riccio, md
phone: 3396770124
email: elyriccio@libero.it
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Eleonora Riccio
investigator title: MD
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Sevelamer