<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/NCT03806998</url>
  </required_header>
  <id_info>
    <org_study_id>Ketosterilrenal</org_study_id>
    <nct_id>NCT03806998</nct_id>
  </id_info>
  <brief_title>Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure</brief_title>
  <official_title>Effects of a Ketoacid Supplementation on Urinary Urea Nitrogen Excretion in Patients With Stage III to IV Renal Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Servicio de Salud Metropolitano Oriente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chile</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 aim of the study is to demonstrate that a ketoacid supplement in patients with stage III&#xD;
      to IV chronic renal failure, reduces the excretion of urinary urea nitrogen&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with an estimated glomerular filtration rate of less than 25 ml/kg/min, not on renal&#xD;
      substitution therapy, without important concomitant diseases and aged between 40 and 70&#xD;
      years, will be invited to participate in the study. They will be randomly assigned to a group&#xD;
      that will receive receive a supplement of ketoacids (Ketosteril) 1 tablet containing 630 mg&#xD;
      of ketoacids every 5 kg of body weight and a diet containing 25 to 35 kcal/kg and 0.3&#xD;
      g/protein per day or to a group receiving placebo and a diet containing 25 to 35 kcal/kg and&#xD;
      0.6 g/protein per day. The intervention will last 16 weeks. At baseline and the end of the&#xD;
      intervention a blood sample will be obtained to measure creatinine, urea nitrogen and&#xD;
      cystatin C. Also a spot urine sample will be obtained to measure urea nitrogen and creatinine&#xD;
      excretion. The compliance with the dietary prescription and the ketoacid or placebo&#xD;
      supplement will be assessed every 2 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</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>
    <intervention_model_description>Participants will be randomly assgned to receive the ketoacid supplement or placebo</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>There will be no masking of the treatment arm for researchers</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Estimated glomerular filtration rate</measure>
    <time_frame>16 weeks</time_frame>
    <description>glomerular filtration rate estimated using the CKD-EPI formula for Cystatin-C</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary urea nitrogen excretion</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measurement of urea nitrogen i na spot urine sample</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Renal Failure</condition>
  <arm_group>
    <arm_group_label>Ketoacid supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive a ketoacid supplement containing 630 mg of ketoacids in a dose of 1 tablet every 5 kg of body weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Will receive placebo tablets in a dose of 1 tablet every 5 kg of body weight</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ketoacids</intervention_name>
    <description>Provision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks</description>
    <arm_group_label>Ketoacid supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Provision of placebo capsules similar to active supplement</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Estimated glomerular filtration rate of less tan 25/ml/min/1.73m2&#xD;
&#xD;
          -  Not on renal substitution therapy&#xD;
&#xD;
          -  Absence of severe life threatening concomitant diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Malignant or renovascular hypertension&#xD;
&#xD;
          -  Use of systemic steroids or immunosuppressant drugs&#xD;
&#xD;
          -  Alcohol or illicit drug abuse&#xD;
&#xD;
          -  A body mass index of less tan 18 kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Bunout, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>INTA University of Chile</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital del Salvador</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>Eduardo Lorca</investigator_full_name>
    <investigator_title>Chief Cardiovascular Program</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 29, 2019</submitted>
    <returned>July 26, 2019</returned>
  </pending_results>
  <!-- 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/NCT03806998
org study id: Ketosterilrenal
nct id: NCT03806998
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to demonstrate that a ketoacid supplement in patients with stage III
      to IV chronic renal failure, reduces the excretion of urinary urea nitrogen
Patients with an estimated glomerular filtration rate of less than 25 ml/kg/min, not on renal
      substitution therapy, without important concomitant diseases and aged between 40 and 70
      years, will be invited to participate in the study. They will be randomly assigned to a group
      that will receive receive a supplement of ketoacids (Ketosteril) 1 tablet containing 630 mg
      of ketoacids every 5 kg of body weight and a diet containing 25 to 35 kcal/kg and 0.3
      g/protein per day or to a group receiving placebo and a diet containing 25 to 35 kcal/kg and
      0.6 g/protein per day. The intervention will last 16 weeks. At baseline and the end of the
      intervention a blood sample will be obtained to measure creatinine, urea nitrogen and
      cystatin C. Also a spot urine sample will be obtained to measure urea nitrogen and creatinine
      excretion. The compliance with the dietary prescription and the ketoacid or placebo
      supplement will be assessed every 2 weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assgned to receive the ketoacid supplement or placebo
primary purpose: Treatment
masking: Single (Participant)
masking description: There will be no masking of the treatment arm for researchers
measure: Estimated glomerular filtration rate
time frame: 16 weeks
description: glomerular filtration rate estimated using the CKD-EPI formula for Cystatin-C
measure: Urinary urea nitrogen excretion
time frame: 16 weeks
description: Measurement of urea nitrogen i na spot urine sample
arm group label: Ketoacid supplementation
arm group type: Experimental
description: Will receive a ketoacid supplement containing 630 mg of ketoacids in a dose of 1 tablet every 5 kg of body weight
arm group label: Placebo
arm group type: Placebo Comparator
description: Will receive placebo tablets in a dose of 1 tablet every 5 kg of body weight
intervention type: Dietary Supplement
intervention name: Ketoacids
description: Provision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks
arm group label: Ketoacid supplementation
intervention type: Dietary Supplement
intervention name: Placebo
description: Provision of placebo capsules similar to active supplement
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Daniel Bunout, MD
role: Principal Investigator
affiliation: INTA University of Chile
facility: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: University of Chile
investigator full name: Eduardo Lorca
investigator title: Chief Cardiovascular Program
mesh term: Renal Insufficiency
submitted: May 29, 2019
returned: July 26, 2019