<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/NCT03010072</url>
  </required_header>
  <id_info>
    <org_study_id>PA21-T50-CKD5D</org_study_id>
    <nct_id>NCT03010072</nct_id>
  </id_info>
  <brief_title>The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum</brief_title>
  <official_title>The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prim. Priv. Doz. Dr. Daniel Cejka</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vifor Fresenius Medical Care Renal Pharma</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, controlled, randomized, cross-over study in&#xD;
      34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with&#xD;
      hyperphosphatemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomized in a 1:1 ratio to either receive low-dose (250mg/d) PA-21&#xD;
      followed by high-dose (2000mg/d) PA-21 (sequence A-B) or to receive high-dose PA21 followed&#xD;
      by low-dose PA21 (sequence B-A) with washout-phases in between. An open label design with a&#xD;
      sub-therapeutic dose of PA21 as control treatment was chosen because creating a convincing&#xD;
      placebo for PA21 is not feasible.&#xD;
&#xD;
      The study will start with two study visits on the 2nd and 3rd dialysis session of the week ,&#xD;
      where dialysis patients are still treated with standard of care to establish baseline values&#xD;
      (duration: 0.5 weeks). Next will be an initial run-in wash-out phase, where all phosphate&#xD;
      binders taken by the patient as standard of care treatment will be discontinued and no&#xD;
      phosphate binders will be introduced. Consequently, there will be a PA21 treatment (high&#xD;
      dose/low dose) phase, followed by a wash-out phase, followed by another PA21 treatment (high&#xD;
      dose/low dose) phase, followed by a final wash-out phase. Each study phase, including&#xD;
      wash-out phases as well as low-dose and high-dose treatment phases will be 14 days of&#xD;
      duration. Patients will be followed up to 10.5 weeks after randomization until the last study&#xD;
      visit of the final wash-out phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 9, 2017</start_date>
  <completion_date type="Actual">May 10, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Propensity of serum for calcification - H1</measure>
    <time_frame>10.5 weeks</time_frame>
    <description>The primary outcome is change in the mean T50- Test values between different study phases (wash-out/treatment/control).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Serum Phosphate</measure>
    <time_frame>10.5 weeks</time_frame>
    <description>The secondary outcome is the Change of mean Serum Phosphate Levels between different study visits</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Endstage Renal Disease</condition>
  <arm_group>
    <arm_group_label>low-dose sucroferric oxyhydroxide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low dose 250 mg sucroferric oxyhydroxide (PA21) per day (1x 250mg tablets/day) for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high-dose sucroferric oxyhydroxide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Uniform dose 2000 mg of sucroferric oxyhydroxide (PA21) per day (4x 500mg tablets/day) for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>low-dose sucroferric oxyhydroxide</intervention_name>
    <description>250 mg suroferric oxyhydroxide</description>
    <arm_group_label>low-dose sucroferric oxyhydroxide</arm_group_label>
    <other_name>suroferric oxyhydroxide tablets</other_name>
    <other_name>Velphoro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>high-dose sucroferric oxyhydroxide</intervention_name>
    <description>2000 mg suroferric oxyhydroxide</description>
    <arm_group_label>high-dose sucroferric oxyhydroxide</arm_group_label>
    <other_name>suroferric oxyhydroxide tablets</other_name>
    <other_name>Velphoro</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prevalent patients (≥ 3 months on dialysis) treated with thrice weekly hemodialysis&#xD;
             (HD) or hemodiafiltration (HDF)&#xD;
&#xD;
          -  Hyperphosphatemia (serum phosphate &gt; upper limit of normal within the last 3 months)&#xD;
             or current phosphate binder use&#xD;
&#xD;
          -  No use or constant dose of vitamin D and/or calcimimetics for ≥2 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to sucroferric oxyhydroxide (PA21), to other ingredients of Velphoro or to any&#xD;
             iron-medication&#xD;
&#xD;
          -  Current or history of calciphylaxis (calcific uremic arteriolopathy - CUA)&#xD;
&#xD;
          -  parathormone &gt;800 pg/ml&#xD;
&#xD;
          -  Parathyreoidektomie planned or expected&#xD;
&#xD;
          -  Significant GI or hepatic disorders&#xD;
&#xD;
          -  Hypercalcemia (total serum calcium &gt;2.6 mmol/l) at screening&#xD;
&#xD;
          -  Antacids containing aluminum, calcium, magnesium or bicarbonate&#xD;
&#xD;
          -  Oral iron treatments/supplements&#xD;
&#xD;
          -  Pregnant and nursing (lactating) women&#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>Daniel Cejka, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sponsor/PI</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>July 2019</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>July 19, 2019</last_update_submitted>
  <last_update_submitted_qc>July 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2019</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>Prim. Priv. Doz. Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ferric Compounds</mesh_term>
  </intervention_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/NCT03010072
org study id: PA21-T50-CKD5D
nct id: NCT03010072
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single-center, prospective, open-label, controlled, randomized, cross-over study in
      34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with
      hyperphosphatemia.
Patients will be randomized in a 1:1 ratio to either receive low-dose (250mg/d) PA-21
      followed by high-dose (2000mg/d) PA-21 (sequence A-B) or to receive high-dose PA21 followed
      by low-dose PA21 (sequence B-A) with washout-phases in between. An open label design with a
      sub-therapeutic dose of PA21 as control treatment was chosen because creating a convincing
      placebo for PA21 is not feasible.

      The study will start with two study visits on the 2nd and 3rd dialysis session of the week ,
      where dialysis patients are still treated with standard of care to establish baseline values
      (duration: 0.5 weeks). Next will be an initial run-in wash-out phase, where all phosphate
      binders taken by the patient as standard of care treatment will be discontinued and no
      phosphate binders will be introduced. Consequently, there will be a PA21 treatment (high
      dose/low dose) phase, followed by a wash-out phase, followed by another PA21 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 days of
      duration. Patients will be followed up to 10.5 weeks after randomization until the last study
      visit of the final wash-out phase.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Propensity of serum for calcification - H1
time frame: 10.5 weeks
description: The primary outcome is change in the mean T50- Test values between different study phases (wash-out/treatment/control).
measure: Change in Serum Phosphate
time frame: 10.5 weeks
description: The secondary outcome is the Change of mean Serum Phosphate Levels between different study visits
arm group label: low-dose sucroferric oxyhydroxide
arm group type: Active Comparator
description: Low dose 250 mg sucroferric oxyhydroxide (PA21) per day (1x 250mg tablets/day) for 14 days.
arm group label: high-dose sucroferric oxyhydroxide
arm group type: Active Comparator
description: Uniform dose 2000 mg of sucroferric oxyhydroxide (PA21) per day (4x 500mg tablets/day) for 14 days
intervention type: Drug
intervention name: low-dose sucroferric oxyhydroxide
description: 250 mg suroferric oxyhydroxide
arm group label: low-dose sucroferric oxyhydroxide
other name: suroferric oxyhydroxide tablets
other name: Velphoro
intervention type: Drug
intervention name: high-dose sucroferric oxyhydroxide
description: 2000 mg suroferric oxyhydroxide
arm group label: high-dose sucroferric oxyhydroxide
other name: suroferric oxyhydroxide tablets
other name: Velphoro
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Cejka, Dr.
role: Principal Investigator
affiliation: Sponsor/PI
facility: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Elisabethinen Hospital
investigator full name: Prim. Priv. Doz. Dr. Daniel Cejka
investigator title: Prim. Priv. Doz. Dr.
mesh term: Kidney Failure, Chronic
mesh term: Ferric Compounds
sharing ipd: No