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/NCT05970094</url>
    </required_header>
    <id_info>
      <org_study_id>H-21069570</org_study_id>
      <nct_id>NCT05970094</nct_id>
    </id_info>
    <brief_title>Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5</brief_title>
    <acronym>REMA-CKD</acronym>
    <official_title>Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Copenhagen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Nordsjaellands Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Copenhagen</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 goal of this clinical trial is to learn about and test the effect of an acid/base diet,&#xD;
        in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a&#xD;
        historical control.&#xD;
  &#xD;
        Our hypothesize is that an acid/base diet will reduce the degree of acidosis and the need for&#xD;
        oral bicarbonate supplements.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Observational studies indicate that diets with a low &quot;potential renal acid load (PRAL)&quot; is&#xD;
        associated with a lower serum-bicarobante value. Therefore we aim to investigate this&#xD;
        association with an interventional studydesign.&#xD;
  &#xD;
        Participants will be asked to follow a restricted diet with a low &quot;PRAL&quot; during a 6 week&#xD;
        trial divided in three periodes: two week free living control, two week intervention and a&#xD;
        two week free living follow-up.&#xD;
  &#xD;
        The PRAL calculation tool will be used to create a diet low in acid, based on this the&#xD;
        patients will recieve individual diet plans. The diet will comply with national treshold&#xD;
        guidlines for potassium and protein, this is due to the high risk of hyperkalemia in patients&#xD;
        with chronic kidney disease. The patients will be asked to document their food and drink&#xD;
        intake by taking pictures of their plates and cups before and after a meal, over a 24 hour&#xD;
        period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 6, 2023</start_date>
    <completion_date type="Anticipated">November 20, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 20, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Plasma-total CO2</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/l</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plasma-alkaline phosphatase</measure>
      <time_frame>6 weeks</time_frame>
      <description>U/l</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma-sodium ion</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/l</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma-creatinine</measure>
      <time_frame>6 weeks</time_frame>
      <description>umol/l</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma-parathyroid hormone</measure>
      <time_frame>6 weeks</time_frame>
      <description>pmol/l</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma-carbamide</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/l</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma-albumin</measure>
      <time_frame>6 weeks</time_frame>
      <description>g/l</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine-phosphorous</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/d</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine-sodium</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/d</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine-potassium</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/d</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine-carbamide</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/d</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine-albumin</measure>
      <time_frame>6 weeks</time_frame>
      <description>mg/d</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine-magnesium</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/d</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine-creatinine</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/d</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Uirne-calcium</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/d</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total acid excretion in urine</measure>
      <time_frame>6 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine-pH</measure>
      <time_frame>6 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine NH4+ excretion</measure>
      <time_frame>6 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine net acid excretion</measure>
      <time_frame>6 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine bicarbonate</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/l</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Plasma-Potassium</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/l</description>
    </other_outcome>
    <other_outcome>
      <measure>Plasma-calcium</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/l</description>
    </other_outcome>
    <other_outcome>
      <measure>Plasma-magnesium</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/l</description>
    </other_outcome>
    <other_outcome>
      <measure>Plasma-inorganic phosphorous</measure>
      <time_frame>6 weeks</time_frame>
      <description>mmol/l</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">20</enrollment>
    <condition>Kidney Diseases</condition>
    <condition>Metabolic Acidosis</condition>
    <condition>Renal Insufficiency</condition>
    <condition>CKD</condition>
    <condition>Pre-dialysis</condition>
    <arm_group>
      <arm_group_label>Low PRAL diet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Low PRAL</intervention_name>
      <description>Two weeks on a low PRAL diet compared to 2 week free living</description>
      <arm_group_label>Low PRAL diet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Chronic acidosis (plasma-bicarbonat under 22 mmol/l at multiple measures within the&#xD;
               last 12 months).&#xD;
  &#xD;
            -  Diagnosed with non-dialysis needed chronic kidney disease in stage 4 and 5 (eGFR below&#xD;
               30 ml/min/1,73 m2)&#xD;
  &#xD;
            -  Of legal age and over 18 of years&#xD;
  &#xD;
            -  Understand danish and understand the written material&#xD;
  &#xD;
            -  Able to cooperate about the diet&#xD;
  &#xD;
            -  Able to take pictures with their phone or willing to learn&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Vegan and vegetarian with very low intake of animal protein (below 25 g/day)&#xD;
  &#xD;
            -  Pregnant or breast feeding&#xD;
  &#xD;
            -  Patients with short bowel syndrome, brickre's bladder, pancreatitis or any other known&#xD;
               malabsorption problem&#xD;
  &#xD;
            -  Potassium above 5 mmol/l&#xD;
  &#xD;
            -  Ongoing infection&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Nordshjaellands Hospital</name>
        <address>
          <city>Hillerød</city>
          <zip>3400</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 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>Potential renal acid load</keyword>
    <keyword>PRAL</keyword>
    <keyword>Study design</keyword>
    <keyword>Diet</keyword>
    <keyword>Humans</keyword>
    <keyword>Elderly</keyword>
    <keyword>Bicarbonate/blood</keyword>
    <keyword>Muscle strength</keyword>
    <keyword>Hand strength</keyword>
    <keyword>Chair stand test</keyword>
    <keyword>Calorimetry, indirect</keyword>
    <keyword>Bone mineralization</keyword>
    <keyword>Carbon dioxide/blood</keyword>
    <keyword>Phosphor/urine</keyword>
    <keyword>Potassium/urine</keyword>
    <keyword>Urea/blood</keyword>
    <keyword>Urea/urine</keyword>
    <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>
      <mesh_term>Renal Insufficiency</mesh_term>
      <mesh_term>Acidosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Currently no plans for sharing</ipd_description>
    </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/NCT05970094
  org study id: H-21069570
  nct id: NCT05970094
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about and test the effect of an acid/base diet,
        in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a
        historical control.
  
        Our hypothesize is that an acid/base diet will reduce the degree of acidosis and the need for
        oral bicarbonate supplements.
  Observational studies indicate that diets with a low "potential renal acid load (PRAL)" is
        associated with a lower serum-bicarobante value. Therefore we aim to investigate this
        association with an interventional studydesign.
  
        Participants will be asked to follow a restricted diet with a low "PRAL" during a 6 week
        trial divided in three periodes: two week free living control, two week intervention and a
        two week free living follow-up.
  
        The PRAL calculation tool will be used to create a diet low in acid, based on this the
        patients will recieve individual diet plans. The diet will comply with national treshold
        guidlines for potassium and protein, this is due to the high risk of hyperkalemia in patients
        with chronic kidney disease. The patients will be asked to document their food and drink
        intake by taking pictures of their plates and cups before and after a meal, over a 24 hour
        period.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Plasma-total CO2
  time frame: 6 weeks
  description: mmol/l
  measure: Plasma-alkaline phosphatase
  time frame: 6 weeks
  description: U/l
  measure: Plasma-sodium ion
  time frame: 6 weeks
  description: mmol/l
  measure: Plasma-creatinine
  time frame: 6 weeks
  description: umol/l
  measure: Plasma-parathyroid hormone
  time frame: 6 weeks
  description: pmol/l
  measure: Plasma-carbamide
  time frame: 6 weeks
  description: mmol/l
  measure: Plasma-albumin
  time frame: 6 weeks
  description: g/l
  measure: Urine-phosphorous
  time frame: 6 weeks
  description: mmol/d
  measure: Urine-sodium
  time frame: 6 weeks
  description: mmol/d
  measure: Urine-potassium
  time frame: 6 weeks
  description: mmol/d
  measure: Urine-carbamide
  time frame: 6 weeks
  description: mmol/d
  measure: Urine-albumin
  time frame: 6 weeks
  description: mg/d
  measure: Urine-magnesium
  time frame: 6 weeks
  description: mmol/d
  measure: Urine-creatinine
  time frame: 6 weeks
  description: mmol/d
  measure: Uirne-calcium
  time frame: 6 weeks
  description: mmol/d
  measure: Total acid excretion in urine
  time frame: 6 weeks
  measure: Urine-pH
  time frame: 6 weeks
  measure: Urine NH4+ excretion
  time frame: 6 weeks
  measure: Urine net acid excretion
  time frame: 6 weeks
  measure: Urine bicarbonate
  time frame: 6 weeks
  description: mmol/l
  measure: Plasma-Potassium
  time frame: 6 weeks
  description: mmol/l
  measure: Plasma-calcium
  time frame: 6 weeks
  description: mmol/l
  measure: Plasma-magnesium
  time frame: 6 weeks
  description: mmol/l
  measure: Plasma-inorganic phosphorous
  time frame: 6 weeks
  description: mmol/l
  arm group label: Low PRAL diet
  arm group type: Experimental
  description: Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
  intervention type: Other
  intervention name: Low PRAL
  description: Two weeks on a low PRAL diet compared to 2 week free living
  arm group label: Low PRAL diet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Denmark
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  mesh term: Renal Insufficiency
  mesh term: Acidosis
  sharing ipd: Undecided
  ipd description: Currently no plans for sharing