<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/NCT03301558</url>
  </required_header>
  <id_info>
    <org_study_id>KTR-Bic-T50</org_study_id>
    <nct_id>NCT03301558</nct_id>
  </id_info>
  <brief_title>The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients</brief_title>
  <official_title>The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prim. Priv. Doz. Dr. Daniel Cejka</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medice Arzneimittel Pütter GmbH &amp; Co KG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Elisabethinen Hospital</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>
      This is a single-center, prospective, open-label, randomized, cross-over study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary hypothesis (H1) is that the T50 value will change between wash-out and high-dose&#xD;
      (3000mg/d) sodium bicarbonate (Nephrotrans®) substitution.&#xD;
&#xD;
      The 0-hypothesis (H0) is that substitution of 3000 mg/d sodium bicarbonate (Nephrotrans®) has&#xD;
      no effect on T50-values as compared to wash-out-phase.&#xD;
&#xD;
      Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium&#xD;
      bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive&#xD;
      high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with&#xD;
      washout-phases in between.&#xD;
&#xD;
      Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium&#xD;
      bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive&#xD;
      high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with&#xD;
      washout-phases in between. The study will start with an initial run-in wash-out phase, where&#xD;
      all sodium bicarbonate or other alkalizing treatment taken by the patient as standard of care&#xD;
      will be discontinued. Consequently, there will be a sodium bicarbonate treatment (high&#xD;
      dose/low dose) phase, followed by a wash-out phase, followed by another sodium bicarbonate&#xD;
      treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase,&#xD;
      including wash-out phases as well as low-dose and high-dose treatment phases will be 14 ±3&#xD;
      days of duration. Patients will be followed up to 12weeks after randomization until the last&#xD;
      study visit of the final wash-out phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    study not started due to organizational reasons&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 1, 2024</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Propensity of serum for calcification</measure>
    <time_frame>12 weeks</time_frame>
    <description>The primary outcome is change in the mean T50 values between different study phases (treatment vs. control).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum bicarbonate levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>The secondary outcome is change of serum bicarbonate levels between different study phases.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Kidney Transplant; Complications</condition>
  <arm_group>
    <arm_group_label>Low dose sodium bicarbonate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low dose 1500 mg sodium bicarbonate (Nephrotrans®) per day (500mg tablets 3x/day) for 14 ± 3 days. The patients will be advised to take one capsule with breakfast, one with lunch and one with dinner (schedule 1-1-1).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose sodium bicarbonate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High dose 3000 mg of sodium bicarbonate (Nephrotrans®) per day (500mg tablets 3x/day) for 14 ± 3 days. The patients will be advised to take two capsules with breakfast, two with lunch and two with dinner (schedule 2-2-2).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose sodium bicarbonate</intervention_name>
    <description>1500 mg sodium bicarbonate</description>
    <arm_group_label>Low dose sodium bicarbonate</arm_group_label>
    <other_name>Nephrotrans</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose sodium bicarbonate</intervention_name>
    <description>3000 mg sodium bicarbonate</description>
    <arm_group_label>High Dose sodium bicarbonate</arm_group_label>
    <other_name>Nephrotrans</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults ≥ 18 years old&#xD;
&#xD;
          -  Prevalent (≥ 6 months after kidney transplantation) kidney transplant recipients&#xD;
&#xD;
          -  eGFR (CKD-EPI formula) between 10 and 50 ml/min/1.73 m²&#xD;
&#xD;
          -  Patient has provided informed consent prior to initiation of any study related&#xD;
             procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to sodium bicarbonate or any component of Nephrotrans®, namely soy or peanuts&#xD;
             (reported cross-reactivity to peanuts has been reported in patients with soy-allergy).&#xD;
&#xD;
          -  Unstable clinical condition (e.g. uncontrolled heart failure, clinical uremia,&#xD;
             uncontrolled hypertension, impending initiation of dialysis treatment…) as judged by&#xD;
             the recruiting physician&#xD;
&#xD;
          -  Pregnant and nursing (lactating) women&#xD;
&#xD;
          -  Unwillingness to discontinue current medication with sodium bicarbonate&#xD;
&#xD;
          -  Unwillingness to discontinue antacids containing aluminum, calcium carbonate,&#xD;
             magnesium, lactate, citrate, bicarbonate or mixtures thereof&#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>Daniela Cejka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of Nephrology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ordensklinikum Linz GmbH Elisabethinen</name>
      <address>
        <city>Linz</city>
        <state>Upper Austria</state>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Elisabethinen Hospital</investigator_affiliation>
    <investigator_full_name>Prim. Priv. Doz. Dr. Daniel Cejka</investigator_full_name>
    <investigator_title>Head of Nephrology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcinosis</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/NCT03301558
org study id: KTR-Bic-T50
nct id: NCT03301558
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single-center, prospective, open-label, randomized, cross-over study.
The primary hypothesis (H1) is that the T50 value will change between wash-out and high-dose
      (3000mg/d) sodium bicarbonate (Nephrotrans®) substitution.

      The 0-hypothesis (H0) is that substitution of 3000 mg/d sodium bicarbonate (Nephrotrans®) has
      no effect on T50-values as compared to wash-out-phase.

      Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium
      bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive
      high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with
      washout-phases in between.

      Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium
      bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive
      high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with
      washout-phases in between. The study will start with an initial run-in wash-out phase, where
      all sodium bicarbonate or other alkalizing treatment taken by the patient as standard of care
      will be discontinued. Consequently, there will be a sodium bicarbonate treatment (high
      dose/low dose) phase, followed by a wash-out phase, followed by another sodium bicarbonate
      treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase,
      including wash-out phases as well as low-dose and high-dose treatment phases will be 14 ±3
      days of duration. Patients will be followed up to 12weeks after randomization until the last
      study visit of the final wash-out phase.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Propensity of serum for calcification
time frame: 12 weeks
description: The primary outcome is change in the mean T50 values between different study phases (treatment vs. control).
measure: Serum bicarbonate levels
time frame: 12 weeks
description: The secondary outcome is change of serum bicarbonate levels between different study phases.
arm group label: Low dose sodium bicarbonate
arm group type: Active Comparator
description: Low dose 1500 mg sodium bicarbonate (Nephrotrans®) per day (500mg tablets 3x/day) for 14 ± 3 days. The patients will be advised to take one capsule with breakfast, one with lunch and one with dinner (schedule 1-1-1).
arm group label: High Dose sodium bicarbonate
arm group type: Active Comparator
description: High dose 3000 mg of sodium bicarbonate (Nephrotrans®) per day (500mg tablets 3x/day) for 14 ± 3 days. The patients will be advised to take two capsules with breakfast, two with lunch and two with dinner (schedule 2-2-2).
intervention type: Drug
intervention name: Low dose sodium bicarbonate
description: 1500 mg sodium bicarbonate
arm group label: Low dose sodium bicarbonate
other name: Nephrotrans
intervention type: Drug
intervention name: High dose sodium bicarbonate
description: 3000 mg sodium bicarbonate
arm group label: High Dose sodium bicarbonate
other name: Nephrotrans
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniela Cejka, MD
role: Principal Investigator
affiliation: Head of Nephrology
facility: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Elisabethinen Hospital
investigator full name: Prim. Priv. Doz. Dr. Daniel Cejka
investigator title: Head of Nephrology
mesh term: Calcinosis
sharing ipd: No