xml: <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/NCT05968391</url>
    </required_header>
    <id_info>
      <org_study_id>2024-5157</org_study_id>
      <nct_id>NCT05968391</nct_id>
    </id_info>
    <brief_title>Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)</brief_title>
    <acronym>RENO-TEP</acronym>
    <official_title>Comparison of Acetoacetate and Acetate Kidney Uptake in Patients With Chronic Kidney Failure Measured by Positron Emission Tomography : the RENO-TEP Project</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Université de Sherbrooke</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Nestle Health Science</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Université de Sherbrooke</source>
    <oversight_info>
      <has_dmc>No</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 objective of this study is to nake a comparison between 11c-acetate and 11c-acetoacetate&#xD;
        kidney uptake in chronic kidney failure patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic kidney failure patients will be ask to perform two positron emission tomography scan&#xD;
        during the same day. One, with a 11C-Acetate Tracer and the other with 11C-Acetoacetate. The&#xD;
        results will allow to determine the difference between the two tracers and will ultimately be&#xD;
        compared with precedent results of healthy controls.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Mean in kidney acetate uptake</measure>
      <time_frame>30 minutes</time_frame>
      <description>Kidney acetate uptake measured by pet scan</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean in kidney acetoacetate uptake</measure>
      <time_frame>30 minutes</time_frame>
      <description>Kidney acetoacetate uptake measured by pet scan</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean in kidney acetoacetate metabolism</measure>
      <time_frame>30 minutes</time_frame>
      <description>Kidney acetoacetate metabolism measured by pet scan</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean in kidney acetate metabolism</measure>
      <time_frame>30 minutes</time_frame>
      <description>Kidney acetate metabolism measured by pet scan</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean in heart ejection fraction</measure>
      <time_frame>30 minutes</time_frame>
      <description>Ejection fraction measured by pet scan</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Kidney Failure, Chronic</condition>
    <arm_group>
      <arm_group_label>Chronic kidney failure</arm_group_label>
      <description>No interventions for the purpose of the study. They will simply undergo two PET scans consecutively</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>PET scan metabolic day</intervention_name>
      <description>11C-Acetate and 11C-Acetoacetate PET scans</description>
      <arm_group_label>Chronic kidney failure</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          People with kidney failure&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  BMI between 18.5 and 40&#xD;
  &#xD;
            -  Kidney failure if GFR betweem 30 and 60 mL/min/1.73m2&#xD;
  &#xD;
            -  Stable medication for at least 4 weeks&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Receive cytotoxic therapy for primary or secondary kidney disease within 6 months&#xD;
               prior to enrollment&#xD;
  &#xD;
            2. Organ Transplant History&#xD;
  &#xD;
            3. Class IV congestive heart failure (New York Heart Association)&#xD;
  &#xD;
            4. Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12&#xD;
               weeks prior to enrollment&#xD;
  &#xD;
            5. Coronary revascularization (percutaneous coronary intervention or arterial bypass) or&#xD;
               valve repair/replacement within 12 weeks of enrollment or is scheduled to undergo one&#xD;
               of these procedures within 4 weeks of enrollment&#xD;
  &#xD;
            6. Any condition outside the realm of renal and cardiovascular disease, such as, but not&#xD;
               limited to, malignancy, with a life expectancy of less than 2 years in the clinical&#xD;
               judgment of the investigator&#xD;
  &#xD;
            7. Active malignancy requiring treatment at Visit 1 (except successfully treated basal or&#xD;
               squamous cell carcinoma).&#xD;
  &#xD;
            8. Hepatic impairment (aspartate transaminase or alanine transaminase &gt;3x upper limit of&#xD;
               normal; or total bilirubin &gt;2x upper limit of normal at time of enrollment&#xD;
  &#xD;
            9. Pregnancy or lactation&#xD;
  &#xD;
           10. Adherence to a ketogenic diet, consumption of ketogenic products or supplements or&#xD;
               intermittent fasting or other diet or supplements that may significantly increase&#xD;
               ketones in the past two months.&#xD;
  &#xD;
           11. Daily alcohol consumption &gt;2 servings per day&#xD;
  &#xD;
           12. Participation in other interventional research projects concurrently or participation&#xD;
               in other PET research projects in the last year, which exceeds the recommended limits&#xD;
  &#xD;
           13. Inability to lie still in supine position;&#xD;
  &#xD;
           14. Medical fluid restriction limiting fluid intake for the procedure&#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_official>
      <last_name>Mélanie Godin, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Université de Sherbrooke</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Valerie St-Pierre, MSc</last_name>
      <phone>8197802220</phone>
      <phone_ext>45286</phone_ext>
      <email>valerie.R.st-pierre@usherbrooke.ca</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ketone</keyword>
    <keyword>acetoacetate</keyword>
    <keyword>acetate</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Renal Insufficiency</mesh_term>
      <mesh_term>Kidney Failure, Chronic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968391
  org study id: 2024-5157
  nct id: NCT05968391
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to nake a comparison between 11c-acetate and 11c-acetoacetate
        kidney uptake in chronic kidney failure patients.
  Chronic kidney failure patients will be ask to perform two positron emission tomography scan
        during the same day. One, with a 11C-Acetate Tracer and the other with 11C-Acetoacetate. The
        results will allow to determine the difference between the two tracers and will ultimately be
        compared with precedent results of healthy controls.
  observational model: Case-Only
  time perspective: Prospective
  measure: Mean in kidney acetate uptake
  time frame: 30 minutes
  description: Kidney acetate uptake measured by pet scan
  measure: Mean in kidney acetoacetate uptake
  time frame: 30 minutes
  description: Kidney acetoacetate uptake measured by pet scan
  measure: Mean in kidney acetoacetate metabolism
  time frame: 30 minutes
  description: Kidney acetoacetate metabolism measured by pet scan
  measure: Mean in kidney acetate metabolism
  time frame: 30 minutes
  description: Kidney acetate metabolism measured by pet scan
  measure: Mean in heart ejection fraction
  time frame: 30 minutes
  description: Ejection fraction measured by pet scan
  arm group label: Chronic kidney failure
  description: No interventions for the purpose of the study. They will simply undergo two PET scans consecutively
  intervention type: Radiation
  intervention name: PET scan metabolic day
  description: 11C-Acetate and 11C-Acetoacetate PET scans
  arm group label: Chronic kidney failure
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mélanie Godin, MD
  role: Principal Investigator
  affiliation: Université de Sherbrooke
  last name: Valerie St-Pierre, MSc
  phone: 8197802220
  phone ext: 45286
  email: valerie.R.st-pierre@usherbrooke.ca
  responsible party type: Sponsor
  mesh term: Renal Insufficiency
  mesh term: Kidney Failure, Chronic
  sharing ipd: No