<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/NCT03035812</url>
  </required_header>
  <id_info>
    <org_study_id>AlcalUN</org_study_id>
    <nct_id>NCT03035812</nct_id>
  </id_info>
  <brief_title>Alkalinization by Urologists &amp; Nephrologists</brief_title>
  <acronym>AlcalUN</acronym>
  <official_title>Prospective Evaluation of Oral Alkalinization by Urologists and Nephrologists: Evolution of the Extracellular Compartment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jean-Philippe Bertocchio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Club des Jeunes Néphrologues</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>
      Metabolic acidosis recovers a wide range of diseases in which an oral alkalinization could be&#xD;
      useful. This therapeutic intervention has been said to increase extracellular volume leading&#xD;
      to rising blood pressure. No prospective data has been published in clinical routine. Here,&#xD;
      investigators propose to follow patients in which an oral alkalinization is indicated: blood&#xD;
      pressure, body weight, and a clinical evaluation of the extracellular compartment will be&#xD;
      performed at the beginning and during the follow-up of participants. The principal criterion&#xD;
      of evaluation will be the variation in the extracellular compartment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Metabolic acidosis recovers a wide range of diseases - chronic kidney diseases,&#xD;
      nephrolithiasis, or others - in which an oral alkalinization could be useful. Oral&#xD;
      alkalinization could be performed or by bicarbonate contained in alkaline-based waters or&#xD;
      drug therapies or by citrate. This therapeutic intervention has been said to increase&#xD;
      extracellular volume leading to rising blood pressure, especially due to the amount of daily&#xD;
      sodium load. No prospective data has been published in clinical routine, studying its effects&#xD;
      on extracellular volume nor the blood pressure control.&#xD;
&#xD;
      Here, investigators propose to follow patients in which an oral alkalinization is indicated:&#xD;
      blood pressure, body weight, and a clinical evaluation of the extracellular compartment will&#xD;
      be performed at the beginning and during the follow-up of participants. Initial recorded data&#xD;
      will be: age, gender, prescription (indication, kind of alkali therapy, volume and duration),&#xD;
      body weight, body length, a clinical appreciation of the extracellular compartment, blood&#xD;
      pressure, comorbidities, drug therapy, blood and urine composition. The recorded follow-up&#xD;
      will be: the adherence to treatment, body weight, body length, a clinical appreciation of the&#xD;
      extracellular compartment, blood pressure, adverse events, blood and urine composition.&#xD;
&#xD;
      The principal criterion of evaluation will be the variation in the extracellular compartment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">February 21, 2020</completion_date>
  <primary_completion_date type="Actual">February 21, 2020</primary_completion_date>
  <phase>Phase 4</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>Clinical and biological evaluation before and after an oral alkalinization</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Extracellular compartment M3</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the extracellular compartment by a composite clinical outcome at M3 composed by: body weight (kg), blood pressure (in mmHg, systolic and diastolic), and the presence edema</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Natremia (mM)</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the impact of oral alkali therapy on natremia (mM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine output (l/d)</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the impact of oral alkali therapy on urine output (l/d)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extracellular compartment M6</measure>
    <time_frame>At M6 (month 6)</time_frame>
    <description>Evaluation of the extracellular compartment by a composite clinical outcome at M6 composed by: body weight (kg), blood pressure (in mmHg, systolic and diastolic), and the presence edema</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kalemia (mM)</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the impact of oral alkali therapy on kalemia (mM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood chloride (mM)</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the impact of oral alkali therapy on blood chloride (mM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bicarbonatemia (mM)</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the impact of oral alkali therapy on bicarbonatemia (mM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proteinemia (g/l)</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the impact of oral alkali therapy on proteinemia (mM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albuminemia (g/l)</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the impact of oral alkali therapy on albuminemia (mM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatininemia (microM)</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the impact of oral alkali therapy on creatininemia (mM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Natriuresis (mmol/d)</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the impact of oral alkali therapy on natriuresis (mmol/d)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine chloride (mmol/d)</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the impact of oral alkali therapy on urine chloride (mmol/d)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proteinuria (g/d)</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the impact of oral alkali therapy on proteinuria (g/d)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinuria (mmol/d)</measure>
    <time_frame>At M3 (month 3)</time_frame>
    <description>Evaluation of the impact of oral alkali therapy on creatinuria (mmol/d)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Metabolic Acidosis</condition>
  <condition>Nephrolithiasis</condition>
  <condition>Extracellular Alteration</condition>
  <condition>Blood Pressure</condition>
  <condition>Body Weight</condition>
  <arm_group>
    <arm_group_label>Alkali</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in whom an oral alkalinization whatever the formulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alkali</intervention_name>
    <description>Oral intake of alkali therapy whatever the formulation (alkali-based water, powder or pharmaceutics)</description>
    <arm_group_label>Alkali</arm_group_label>
    <other_name>Bicarbonate</other_name>
    <other_name>Citrate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; or = to 18 years old&#xD;
&#xD;
          -  in whom an oral alkalinization is indicated&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  if the patient mentions its opposition to his/her enrollment&#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>Julie Beaume, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Club des Jeunes Néphrologues</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu</name>
      <address>
        <city>Bourgoin</city>
        <zip>38300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Cavale Blanche Hospital</name>
      <address>
        <city>Brest</city>
        <zip>29600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHMS Chambery</name>
      <address>
        <city>Chambéry</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calydial</name>
      <address>
        <city>Irigny</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>E.C.H.O. (Expansion des Centres d'Hémodialyse de l'Ouest)</name>
      <address>
        <city>Le Mans</city>
        <zip>72016</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Conception University Hospital, AP-HM</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Phocéen de Néphrologie, Clinique Bouchard</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uninversity Hospital of Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURA Paris Plaisance</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>European Georges Pompidou Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75908</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tenon Hospital, AP-HP</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maison Blanche Hospital</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rennes Hospital</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aub Sante</name>
      <address>
        <city>Saint Malo</city>
        <zip>35400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic area</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Sainte Anne</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HIA Sainte-Anne</name>
      <address>
        <city>Toulon</city>
        <zip>83000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Club des Jeunes Néphrologues</investigator_affiliation>
    <investigator_full_name>Jean-Philippe Bertocchio</investigator_full_name>
    <investigator_title>President, Investigator</investigator_title>
  </responsible_party>
  <keyword>Bicarbonate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Acidosis</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03035812
org study id: AlcalUN
nct id: NCT03035812
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Metabolic acidosis recovers a wide range of diseases in which an oral alkalinization could be
      useful. This therapeutic intervention has been said to increase extracellular volume leading
      to rising blood pressure. No prospective data has been published in clinical routine. Here,
      investigators propose to follow patients in which an oral alkalinization is indicated: blood
      pressure, body weight, and a clinical evaluation of the extracellular compartment will be
      performed at the beginning and during the follow-up of participants. The principal criterion
      of evaluation will be the variation in the extracellular compartment.
Metabolic acidosis recovers a wide range of diseases - chronic kidney diseases,
      nephrolithiasis, or others - in which an oral alkalinization could be useful. Oral
      alkalinization could be performed or by bicarbonate contained in alkaline-based waters or
      drug therapies or by citrate. This therapeutic intervention has been said to increase
      extracellular volume leading to rising blood pressure, especially due to the amount of daily
      sodium load. No prospective data has been published in clinical routine, studying its effects
      on extracellular volume nor the blood pressure control.

      Here, investigators propose to follow patients in which an oral alkalinization is indicated:
      blood pressure, body weight, and a clinical evaluation of the extracellular compartment will
      be performed at the beginning and during the follow-up of participants. Initial recorded data
      will be: age, gender, prescription (indication, kind of alkali therapy, volume and duration),
      body weight, body length, a clinical appreciation of the extracellular compartment, blood
      pressure, comorbidities, drug therapy, blood and urine composition. The recorded follow-up
      will be: the adherence to treatment, body weight, body length, a clinical appreciation of the
      extracellular compartment, blood pressure, adverse events, blood and urine composition.

      The principal criterion of evaluation will be the variation in the extracellular compartment.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Clinical and biological evaluation before and after an oral alkalinization
primary purpose: Treatment
masking: None (Open Label)
measure: Extracellular compartment M3
time frame: At M3 (month 3)
description: Evaluation of the extracellular compartment by a composite clinical outcome at M3 composed by: body weight (kg), blood pressure (in mmHg, systolic and diastolic), and the presence edema
measure: Natremia (mM)
time frame: At M3 (month 3)
description: Evaluation of the impact of oral alkali therapy on natremia (mM)
measure: Urine output (l/d)
time frame: At M3 (month 3)
description: Evaluation of the impact of oral alkali therapy on urine output (l/d)
measure: Extracellular compartment M6
time frame: At M6 (month 6)
description: Evaluation of the extracellular compartment by a composite clinical outcome at M6 composed by: body weight (kg), blood pressure (in mmHg, systolic and diastolic), and the presence edema
measure: Kalemia (mM)
time frame: At M3 (month 3)
description: Evaluation of the impact of oral alkali therapy on kalemia (mM)
measure: Blood chloride (mM)
time frame: At M3 (month 3)
description: Evaluation of the impact of oral alkali therapy on blood chloride (mM)
measure: Bicarbonatemia (mM)
time frame: At M3 (month 3)
description: Evaluation of the impact of oral alkali therapy on bicarbonatemia (mM)
measure: Proteinemia (g/l)
time frame: At M3 (month 3)
description: Evaluation of the impact of oral alkali therapy on proteinemia (mM)
measure: Albuminemia (g/l)
time frame: At M3 (month 3)
description: Evaluation of the impact of oral alkali therapy on albuminemia (mM)
measure: Creatininemia (microM)
time frame: At M3 (month 3)
description: Evaluation of the impact of oral alkali therapy on creatininemia (mM)
measure: Natriuresis (mmol/d)
time frame: At M3 (month 3)
description: Evaluation of the impact of oral alkali therapy on natriuresis (mmol/d)
measure: Urine chloride (mmol/d)
time frame: At M3 (month 3)
description: Evaluation of the impact of oral alkali therapy on urine chloride (mmol/d)
measure: Proteinuria (g/d)
time frame: At M3 (month 3)
description: Evaluation of the impact of oral alkali therapy on proteinuria (g/d)
measure: Creatinuria (mmol/d)
time frame: At M3 (month 3)
description: Evaluation of the impact of oral alkali therapy on creatinuria (mmol/d)
arm group label: Alkali
arm group type: Experimental
description: Patients in whom an oral alkalinization whatever the formulation
intervention type: Drug
intervention name: Alkali
description: Oral intake of alkali therapy whatever the formulation (alkali-based water, powder or pharmaceutics)
arm group label: Alkali
other name: Bicarbonate
other name: Citrate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julie Beaume, MD
role: Principal Investigator
affiliation: Club des Jeunes Néphrologues
facility: 
facility: 
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country: France
responsible party type: Sponsor-Investigator
investigator affiliation: Club des Jeunes Néphrologues
investigator full name: Jean-Philippe Bertocchio
investigator title: President, Investigator
mesh term: Nephrolithiasis
mesh term: Kidney Calculi
mesh term: Acidosis
mesh term: Body Weight
sharing ipd: No