<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/NCT04409132</url>
  </required_header>
  <id_info>
    <org_study_id>RMFPC-26</org_study_id>
    <nct_id>NCT04409132</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.</brief_title>
  <official_title>A Randomized 4 Period Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rockwell Medical Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rockwell Medical Technologies, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the administration of Triferic AVNU intravenously by three&#xD;
      different administration schedules compared to continuous infusion over 3 hours&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-label, randomized, four period sequential study of Triferic AVNU administered&#xD;
      intravenously by three different administration schedules compared to continuous infusion&#xD;
      over 3 hours&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Actual">April 2, 2021</completion_date>
  <primary_completion_date type="Actual">April 2, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D</measure>
    <time_frame>8 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D</measure>
    <time_frame>8 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D</measure>
    <time_frame>8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D</measure>
    <time_frame>8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D</measure>
    <time_frame>8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D</measure>
    <time_frame>8 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Triferic AVNU infusion pre-dialyzer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive one (1) 6.75 mg Fe dose of Triferic AVNU by continuous infusion over 3 hours into the predialyzer blood line.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triferic AVNU for injection at T=0 and T= 3 hours</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive two (2) doses of Triferic AVNU 3.4 mg IV (2.25 mL) at T=0 and T=3 hours of hemodialysis into the venous drip chamber.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triferic AVNU for injection at T=0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive one (1) dose of Triferic AVNU 0.08 mg/kg IV, up to 6.75 mg Fe, at T=0 of hemodialysis into the venous drip chamber.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive three (3) doses of Triferic AVNU 2.25 mg Fe (1.5 mL) at T=0, T=1.5 and T=3.0 hours of hemodialysis into the venous drip chamber.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triferic</intervention_name>
    <description>Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.</description>
    <arm_group_label>Triferic AVNU for injection at T=0</arm_group_label>
    <arm_group_label>Triferic AVNU for injection at T=0 and T= 3 hours</arm_group_label>
    <arm_group_label>Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours</arm_group_label>
    <arm_group_label>Triferic AVNU infusion pre-dialyzer</arm_group_label>
    <other_name>ferric pyrophosphate citrate</other_name>
    <other_name>FPC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult hemodialysis patients ≥18 years of age.&#xD;
&#xD;
          -  Signed informed consent to participate in the study.&#xD;
&#xD;
          -  Stable on hemodialysis prescription for ≥3 months.&#xD;
&#xD;
          -  Able to sustain hemodialysis 3x/week for 3 to 4 hours.&#xD;
&#xD;
          -  Hemoglobin concentration &gt;9.5 g/dL.&#xD;
&#xD;
          -  Serum TSAT ≥20%.&#xD;
&#xD;
          -  Receiving hemodialysis via AV fistula or graft.&#xD;
&#xD;
          -  Able to receive hemodialysis for 4 hours at each session over the duration of the&#xD;
             treatment periods.&#xD;
&#xD;
          -  Able to receive intermittent heparin administration for anticoagulation of the&#xD;
             dialysis circuit.&#xD;
&#xD;
          -  Serum TIBC ≥ 150 µg/dL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active bleeding disorder (GI, skin, nasal…)&#xD;
&#xD;
          -  Receiving hemodialysis via catheter.&#xD;
&#xD;
          -  Receiving IV iron within 10 days of the first on-study hemodialysis treatment.&#xD;
&#xD;
          -  Receiving oral iron within 10 days of the first on-study hemodialysis treatment.&#xD;
&#xD;
          -  Any other condition, that in the opinion of the investigator would not allow&#xD;
             completion of the 4 hemodialysis treatments in the study.&#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>Raymond D Pratt, MD, FACP</last_name>
    <role>Study Director</role>
    <affiliation>Rockwell Medical</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orlando Clinical Research Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>July 12, 2021</last_update_submitted>
  <last_update_submitted_qc>July 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</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/NCT04409132
org study id: RMFPC-26
nct id: NCT04409132
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will investigate the administration of Triferic AVNU intravenously by three
      different administration schedules compared to continuous infusion over 3 hours
An open-label, randomized, four period sequential study of Triferic AVNU administered
      intravenously by three different administration schedules compared to continuous infusion
      over 3 hours
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D
time frame: 8 hours
measure: Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D
time frame: 8 hours
measure: Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D
time frame: 8 hours
measure: Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D
time frame: 8 hours
measure: Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D
time frame: 8 hours
measure: Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D
time frame: 8 hours
arm group label: Triferic AVNU infusion pre-dialyzer
arm group type: Experimental
description: Patients will receive one (1) 6.75 mg Fe dose of Triferic AVNU by continuous infusion over 3 hours into the predialyzer blood line.
arm group label: Triferic AVNU for injection at T=0 and T= 3 hours
arm group type: Experimental
description: Patients will receive two (2) doses of Triferic AVNU 3.4 mg IV (2.25 mL) at T=0 and T=3 hours of hemodialysis into the venous drip chamber.
arm group label: Triferic AVNU for injection at T=0
arm group type: Experimental
description: Patients will receive one (1) dose of Triferic AVNU 0.08 mg/kg IV, up to 6.75 mg Fe, at T=0 of hemodialysis into the venous drip chamber.
arm group label: Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours
arm group type: Experimental
description: Patients will receive three (3) doses of Triferic AVNU 2.25 mg Fe (1.5 mL) at T=0, T=1.5 and T=3.0 hours of hemodialysis into the venous drip chamber.
intervention type: Drug
intervention name: Triferic
description: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
arm group label: Triferic AVNU for injection at T=0
arm group label: Triferic AVNU for injection at T=0 and T= 3 hours
arm group label: Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours
arm group label: Triferic AVNU infusion pre-dialyzer
other name: ferric pyrophosphate citrate
other name: FPC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raymond D Pratt, MD, FACP
role: Study Director
affiliation: Rockwell Medical
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
sharing ipd: No