<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/NCT03256838</url>
  </required_header>
  <id_info>
    <org_study_id>PBB00501</org_study_id>
    <nct_id>NCT03256838</nct_id>
  </id_info>
  <brief_title>Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis</brief_title>
  <official_title>A Long-Term, Open-Label, Prospective Phase IV Study to Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Panion &amp; BF Biotech Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Panion &amp; BF Biotech Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the long-term safety and effectiveness of Nephoxil® for the treatment of&#xD;
      hyperphosphatemia in patients with ESRD undergoing dialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an open-label, prospective, long term, Phase IV study to assess the safety and&#xD;
      efficacy of Nephoxil® in subjects with ESRD on dialysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2017</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>13 months</time_frame>
    <description>Number of subjects with treatment-emergent adverse events (TEAEs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of subjects with treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>13 months</time_frame>
    <description>Percentage of subjects with treatment-emergent adverse events (TEAEs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Phosphorus</measure>
    <time_frame>13 months</time_frame>
    <description>Serum Phosphorus will be assessed by time-course changes of serum phosphorus levels and proportion of subjects achieved target range of serum phosphorus (&gt;=3.5 mg/dL and &lt;=5.5. mg/dL) from baseline to the end-of-treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Serum calcium</measure>
    <time_frame>13 months</time_frame>
    <description>Time-course changes of serum calcium from baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intact plasma parathyroid hormone (iPTH)</measure>
    <time_frame>13 months</time_frame>
    <description>Time-course changes of intact plasma parathyroid hormone (iPTH) from baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ferritin</measure>
    <time_frame>13 months</time_frame>
    <description>Time-course changes of ferritin from baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Transferring saturation (TSAT) percentage</measure>
    <time_frame>13 months</time_frame>
    <description>Time-course changes of transferring saturation (TSAT) percentage from baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum iron</measure>
    <time_frame>13 months</time_frame>
    <description>Time-course changes of serum iron from baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Total iron-binding capacity (TIBC)</measure>
    <time_frame>13 months</time_frame>
    <description>Time-course changes of total iron-binding capacity (TIBC) from baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>13 months</time_frame>
    <description>Time-course changes of hemoglobin from baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dose of IV iron</measure>
    <time_frame>13 months</time_frame>
    <description>Time-course changes of dose of IV iron from baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dose of erythropoiesis stimulating agents (ESA)</measure>
    <time_frame>13 months</time_frame>
    <description>Time-course changes of dose of erythropoiesis stimulating agents (ESA) from baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment adherence</measure>
    <time_frame>13 months</time_frame>
    <description>Prescribed dose and the dose actually taken at each time point will be calculated.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Kidney Failure, Chronic</condition>
  <condition>End-stage Renal Disease</condition>
  <condition>Phosphorus Metabolism Disorders</condition>
  <condition>Hyperphosphatemia</condition>
  <arm_group>
    <arm_group_label>Ferric citrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ferric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferric Citrate</intervention_name>
    <description>Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.</description>
    <arm_group_label>Ferric citrate</arm_group_label>
    <other_name>Nephoxil® Capsules</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Is ≧ 18 years of age on the day of signing informed consent or other age required by&#xD;
             local regulation&#xD;
&#xD;
          2. Willing and able to provide written informed consent&#xD;
&#xD;
          3. ESRD patients who is undergoing hemodialysis 3 times per week and is considered&#xD;
             necessary to receive medication for hyperphosphatemia by his/her treating physician&#xD;
&#xD;
          4. Serum ferritin &lt;1000 ng/mL and transferrin saturation (TSAT) &lt; 50% at the Enrollment&#xD;
             Visit&#xD;
&#xD;
          5. Women of child-bearing potential (WOCBP [defined as women ≤ 50 years of age with a&#xD;
             history of amenorrhea for &lt; 12 months prior to study entry]) who is willing to use an&#xD;
             effective form of contraception during study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has any known contraindication to ferric citrate according to locally approved&#xD;
             prescribing information, include but not limited to the following criteria:&#xD;
&#xD;
             i. Is allergic to ferric citrate ii. Has hypophosphatemia iii. Has hemochromatosis or&#xD;
             iron overload syndromes iv. Has active severe GI disorders&#xD;
&#xD;
          2. Has parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT) within 3&#xD;
             months prior to Enrollment Visit or serum calcium &lt; 7 mg/dL at the Enrollment Visit&#xD;
&#xD;
          3. Has participated in another interventional study for any investigational agent or&#xD;
             device within 30 days prior to enrollment&#xD;
&#xD;
          4. Is currently pregnant or breastfeeding&#xD;
&#xD;
          5. Other unstable medical condition or psychiatric conditions that is considered&#xD;
             unsuitable for this study per Investigator's clinical judgment&#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>Mai-Szu Wu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>80756</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital</name>
      <address>
        <city>Keelung</city>
        <zip>20401</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>22060</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11042</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11101</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>January 9, 2020</last_update_submitted>
  <last_update_submitted_qc>January 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Citric Acid</keyword>
  <keyword>Ferric Compounds</keyword>
  <keyword>Renal Insufficiency</keyword>
  <keyword>Anticoagulants</keyword>
  <keyword>Calcium Chelating Agents</keyword>
  <keyword>Chelating Agents</keyword>
  <keyword>Sequestering Agents</keyword>
  <keyword>Hemodialysis</keyword>
  <keyword>Dialysis</keyword>
  <keyword>Renal Failure</keyword>
  <keyword>Kidney Failure</keyword>
  <keyword>Urologic Diseases</keyword>
  <keyword>Metabolic Disease</keyword>
  <keyword>Kidney Diseases</keyword>
  <keyword>Renal Insufficiency, Chronic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Hyperphosphatemia</mesh_term>
    <mesh_term>Phosphorus Metabolism Disorders</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/NCT03256838
org study id: PBB00501
nct id: NCT03256838
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
To assess the long-term safety and effectiveness of Nephoxil® for the treatment of
      hyperphosphatemia in patients with ESRD undergoing dialysis.
This study is an open-label, prospective, long term, Phase IV study to assess the safety and
      efficacy of Nephoxil® in subjects with ESRD on dialysis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of subjects with treatment-emergent adverse events (TEAEs)
time frame: 13 months
description: Number of subjects with treatment-emergent adverse events (TEAEs)
measure: Percentage of subjects with treatment-emergent adverse events (TEAEs)
time frame: 13 months
description: Percentage of subjects with treatment-emergent adverse events (TEAEs)
measure: Serum Phosphorus
time frame: 13 months
description: Serum Phosphorus will be assessed by time-course changes of serum phosphorus levels and proportion of subjects achieved target range of serum phosphorus (>=3.5 mg/dL and <=5.5. mg/dL) from baseline to the end-of-treatment.
measure: Serum calcium
time frame: 13 months
description: Time-course changes of serum calcium from baseline.
measure: Intact plasma parathyroid hormone (iPTH)
time frame: 13 months
description: Time-course changes of intact plasma parathyroid hormone (iPTH) from baseline.
measure: Ferritin
time frame: 13 months
description: Time-course changes of ferritin from baseline.
measure: Transferring saturation (TSAT) percentage
time frame: 13 months
description: Time-course changes of transferring saturation (TSAT) percentage from baseline.
measure: Serum iron
time frame: 13 months
description: Time-course changes of serum iron from baseline.
measure: Total iron-binding capacity (TIBC)
time frame: 13 months
description: Time-course changes of total iron-binding capacity (TIBC) from baseline.
measure: Hemoglobin
time frame: 13 months
description: Time-course changes of hemoglobin from baseline.
measure: Dose of IV iron
time frame: 13 months
description: Time-course changes of dose of IV iron from baseline.
measure: Dose of erythropoiesis stimulating agents (ESA)
time frame: 13 months
description: Time-course changes of dose of erythropoiesis stimulating agents (ESA) from baseline.
measure: Treatment adherence
time frame: 13 months
description: Prescribed dose and the dose actually taken at each time point will be calculated.
arm group label: Ferric citrate
arm group type: Experimental
description: Ferric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals).
intervention type: Drug
intervention name: Ferric Citrate
description: Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.
arm group label: Ferric citrate
other name: Nephoxil® Capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mai-Szu Wu, M.D.
role: Principal Investigator
affiliation: Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Renal Insufficiency
mesh term: Metabolic Diseases
mesh term: Hyperphosphatemia
mesh term: Phosphorus Metabolism Disorders
sharing ipd: No