<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/NCT03293446</url>
  </required_header>
  <id_info>
    <org_study_id>NL57148.078.16</org_study_id>
    <nct_id>NCT03293446</nct_id>
  </id_info>
  <brief_title>AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls</brief_title>
  <acronym>AC/DC</acronym>
  <official_title>AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasmus Medical Center</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>
      In this study the effect of an acute acid load on the intrarenal renin angiotensin-system is&#xD;
      evaluated in patients with chronic kidney disease and healthy controls&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Metabolic acidosis is one of the metabolic complications of chronic kidney disease (CKD).&#xD;
      Correction of metabolic acidosis in CKD has been shown to prevent further loss of kidney&#xD;
      function over time. Currently, a clinical trial (the BIC-study, MEC-2013-332) is conducted in&#xD;
      which patients with CKD and metabolic acidosis receive sodium bicarbonate, sodium chloride,&#xD;
      or no treatment (time control) to address the hypothesis that the beneficial effects of&#xD;
      acidosis correction are mediated through inhibition of the intrarenal renin-angiotensin&#xD;
      system (RAS). It is unknown, however, if and how acute changes in acid-base status affect the&#xD;
      intrarenal RAS during CKD. In the present study it is hypothesized that an acute acid load&#xD;
      increases the activity of the intrarenal RAS, and that this response is exaggerated in&#xD;
      patients with CKD compared with healthy controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2016</start_date>
  <completion_date type="Actual">November 11, 2018</completion_date>
  <primary_completion_date type="Actual">November 11, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary renin</measure>
    <time_frame>up to 6 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Chronic Kidney Disease stage4</condition>
  <arm_group>
    <arm_group_label>Patients with chronic kidney disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Urinary acidification test</intervention_name>
    <description>Urinary acidification by administration of ammonium chloride (100 mg/kg body weight, given orally) during a single-day hospital admission.</description>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_label>Patients with chronic kidney disease</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patients with CKD:&#xD;
&#xD;
          -  Male or female adults (≥18 years)&#xD;
&#xD;
          -  Chronic kidney disease stage 4 (eGFR: 15-30 ml/min/1.73 m2, calculated using the&#xD;
             CKD-EPI equation)&#xD;
&#xD;
        Healthy controls:&#xD;
&#xD;
          -  Healthy male or female adults (≥ 18 years)&#xD;
&#xD;
          -  Normal kidney function (eGFR &gt; 90 ml/min/1.73 m2, calculated using the CKD-EPI&#xD;
             equation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CKD patients&#xD;
&#xD;
          -  Plasma bicarbonate level &lt; 20.0 mmol/l&#xD;
&#xD;
          -  Serum potassium &gt;5.5 mmol/l&#xD;
&#xD;
          -  Sodium bicarbonate use in the month preceding the test&#xD;
&#xD;
          -  Heart failure (NYHA III or IV)&#xD;
&#xD;
          -  Liver cirrhosis (Child Pugh B or C)&#xD;
&#xD;
          -  Blood pressure &gt;140/90 mmHg despite the use of 3 different anti-hypertensive drugs&#xD;
&#xD;
          -  Kidney transplantation&#xD;
&#xD;
          -  Use of calcineurin inhibitors (these immunosuppressive drugs affect acid-base balance)&#xD;
&#xD;
          -  Known urea cycle disorder&#xD;
&#xD;
          -  Alcoholism or drug use&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current use of antibiotics, NSAIDS or alkalizing drugs (sodium-bicarbonate, citric&#xD;
             acid, potassium citrate, acetazolamide)&#xD;
&#xD;
          -  Inability to adhere to the study protocol (due to language barrier or intellectual&#xD;
             disability)&#xD;
&#xD;
        Healthy controls:&#xD;
&#xD;
          -  eGFR &lt; 90 ml/min/1.73 m2 (calculated using the CKD-EPI equation)&#xD;
&#xD;
          -  Plasma bicarbonate &lt; 20 mmol/l&#xD;
&#xD;
          -  History of, or drugs for, diabetes mellitus&#xD;
&#xD;
          -  History of chronic diarrheal disease&#xD;
&#xD;
          -  Ileostomy/colostomy&#xD;
&#xD;
          -  Known urea cycle disorder&#xD;
&#xD;
          -  Alcoholism or drug use&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current use of antibiotics, antihypertensive drugs, NSAIDS or alkalizing drugs&#xD;
             (sodium-bicarbonate, citric acid, potassium citrate, acetazolamide)&#xD;
&#xD;
          -  Inability to adhere to the study protocol (due to language barrier or intellectual&#xD;
             disability)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>only males</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <zip>3015CN</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>June 19, 2019</last_update_submitted>
  <last_update_submitted_qc>June 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Ewout Hoorn</investigator_full_name>
    <investigator_title>doctor</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03293446
org study id: NL57148.078.16
nct id: NCT03293446
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study the effect of an acute acid load on the intrarenal renin angiotensin-system is
      evaluated in patients with chronic kidney disease and healthy controls
Metabolic acidosis is one of the metabolic complications of chronic kidney disease (CKD).
      Correction of metabolic acidosis in CKD has been shown to prevent further loss of kidney
      function over time. Currently, a clinical trial (the BIC-study, MEC-2013-332) is conducted in
      which patients with CKD and metabolic acidosis receive sodium bicarbonate, sodium chloride,
      or no treatment (time control) to address the hypothesis that the beneficial effects of
      acidosis correction are mediated through inhibition of the intrarenal renin-angiotensin
      system (RAS). It is unknown, however, if and how acute changes in acid-base status affect the
      intrarenal RAS during CKD. In the present study it is hypothesized that an acute acid load
      increases the activity of the intrarenal RAS, and that this response is exaggerated in
      patients with CKD compared with healthy controls.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Urinary renin
time frame: up to 6 hours
arm group label: Patients with chronic kidney disease
arm group type: Experimental
arm group label: Healthy controls
arm group type: Active Comparator
intervention type: Diagnostic Test
intervention name: Urinary acidification test
description: Urinary acidification by administration of ammonium chloride (100 mg/kg body weight, given orally) during a single-day hospital admission.
arm group label: Healthy controls
arm group label: Patients with chronic kidney disease
criteria: 
gender: Male
gender based: Yes
gender description: only males
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Ewout Hoorn
investigator title: doctor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: Undecided