<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/NCT03795558</url>
  </required_header>
  <id_info>
    <org_study_id>Etelcalcetide-T50-CKD5D</org_study_id>
    <nct_id>NCT03795558</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients</brief_title>
  <official_title>A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prim. Priv. Doz. Dr. Daniel Cejka</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amgen</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, dose-escalation, pilot study in 15 end-stage renal&#xD;
      disease patients on chronic hemodialysis with secondary hyperparathyroidism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fifteen prevalent and stable hemodialysis patients with secondary hyperparathyroidism&#xD;
      eligible for treatment with calcium receptor sensitizers according to current KDIGO will be&#xD;
      included.&#xD;
&#xD;
      Study phases will begin and end on the day of the first hemodialysis session of the week.&#xD;
&#xD;
      The run-in phase will last 4 weeks. No calcimimetics will be prescribed during the run-in&#xD;
      phase.&#xD;
&#xD;
      The treatment phase starts with a dose of etelcalcetide is 2.5mg thrice weekly. Etelcalcetide&#xD;
      dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose&#xD;
      of 15mg thrice weekly.&#xD;
&#xD;
      The wash-out Phase starts after completion of the 15mg thrice-weekly phase or in case a&#xD;
      pre-specified safety endpoint is reached, etelcalcetide will be discontinued and patients&#xD;
      will be followed for additional 8 weeks to study any potential reversibility of PTH lowering&#xD;
      on T50 results.&#xD;
&#xD;
      For the individual patient, the study duration will be 9 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 21, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>This is a single-center, prospective, dose-escalation, pilot study. Starting dose 2.5 mg thrice weekly dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>T50-Laboratory Test for measuring calcification</measure>
    <time_frame>32 weeks</time_frame>
    <description>The changes in T50 values between the different study phases will be evaluated as the primary outcome.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Etelcalcetide 2.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etelcalcetide 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etelcalcetide 7,5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etelcalcetide 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etelcalcetide 12,5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etelcalcetide 15 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etelcalcetide</intervention_name>
    <description>Up-Titration</description>
    <arm_group_label>Etelcalcetide 10 mg</arm_group_label>
    <arm_group_label>Etelcalcetide 12,5 mg</arm_group_label>
    <arm_group_label>Etelcalcetide 15 mg</arm_group_label>
    <arm_group_label>Etelcalcetide 2.5 mg</arm_group_label>
    <arm_group_label>Etelcalcetide 5 mg</arm_group_label>
    <arm_group_label>Etelcalcetide 7,5 mg</arm_group_label>
    <other_name>Parsabiv</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;
          -  Secondary hyperparathyroidism defined as PTH levels &gt; 9x ULN according to current&#xD;
             KDIGO guidelines if therapy-naïve, or patients already treated with calcium receptor&#xD;
             sensitizers with PTH &gt; 2x ULN&#xD;
&#xD;
          -  Albumin corrected calcium ≥ 2,08 mmol/l&#xD;
&#xD;
          -  Calcium concentrations of dialysate stable for at least 2 weeks prior to screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently receiving treatment in another investigational device or drug study or&#xD;
             participation in non-interventional studies&#xD;
&#xD;
          -  Current treatment with etelcalcetide (Parsabiv©) or treatment with etelcalcetide&#xD;
             within 3 months prior to study inclusion&#xD;
&#xD;
          -  Patient has known sensitivity to any of the products or components of Parsabiv©&#xD;
&#xD;
          -  Patient has received a parathyroidectomy&#xD;
&#xD;
          -  Parathyroidectomy planned or expected during the study period&#xD;
&#xD;
          -  Elective kidney transplant scheduled during the study period&#xD;
&#xD;
          -  Therapy with bisphosphonates within the past 12 months&#xD;
&#xD;
          -  Therapy with denosumab within the past 6 months&#xD;
&#xD;
          -  Antacids containing aluminum, calcium, magnesium or bicarbonate&#xD;
&#xD;
          -  Patient has a history of symptomatic ventricular arrhythmias or Torsades de Pointes&#xD;
&#xD;
          -  Patient has a history of myocardial infarction, coronary angioplasty, or coronary&#xD;
             arterial bypass grafting within the past 6 months prior to screening.&#xD;
&#xD;
          -  Pregnant or 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, 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>March 2022</verification_date>
  <study_first_submitted>September 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>March 22, 2022</last_update_submitted>
  <last_update_submitted_qc>March 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2022</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 department</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>
  <!-- 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/NCT03795558
org study id: Etelcalcetide-T50-CKD5D
nct id: NCT03795558
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single-center, prospective, dose-escalation, pilot study in 15 end-stage renal
      disease patients on chronic hemodialysis with secondary hyperparathyroidism.
Fifteen prevalent and stable hemodialysis patients with secondary hyperparathyroidism
      eligible for treatment with calcium receptor sensitizers according to current KDIGO will be
      included.

      Study phases will begin and end on the day of the first hemodialysis session of the week.

      The run-in phase will last 4 weeks. No calcimimetics will be prescribed during the run-in
      phase.

      The treatment phase starts with a dose of etelcalcetide is 2.5mg thrice weekly. Etelcalcetide
      dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose
      of 15mg thrice weekly.

      The wash-out Phase starts after completion of the 15mg thrice-weekly phase or in case a
      pre-specified safety endpoint is reached, etelcalcetide will be discontinued and patients
      will be followed for additional 8 weeks to study any potential reversibility of PTH lowering
      on T50 results.

      For the individual patient, the study duration will be 9 months
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: This is a single-center, prospective, dose-escalation, pilot study. Starting dose 2.5 mg thrice weekly dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly.
primary purpose: Diagnostic
masking: None (Open Label)
measure: T50-Laboratory Test for measuring calcification
time frame: 32 weeks
description: The changes in T50 values between the different study phases will be evaluated as the primary outcome.
arm group label: Etelcalcetide 2.5 mg
arm group type: Experimental
description: Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly
arm group label: Etelcalcetide 5 mg
arm group type: Experimental
description: Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly
arm group label: Etelcalcetide 7,5 mg
arm group type: Experimental
description: Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly
arm group label: Etelcalcetide 10 mg
arm group type: Experimental
description: Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly
arm group label: Etelcalcetide 12,5 mg
arm group type: Experimental
description: Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly
arm group label: Etelcalcetide 15 mg
arm group type: Experimental
description: Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly
intervention type: Drug
intervention name: Etelcalcetide
description: Up-Titration
arm group label: Etelcalcetide 10 mg
arm group label: Etelcalcetide 12,5 mg
arm group label: Etelcalcetide 15 mg
arm group label: Etelcalcetide 2.5 mg
arm group label: Etelcalcetide 5 mg
arm group label: Etelcalcetide 7,5 mg
other name: Parsabiv
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel 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 department
mesh term: Kidney Failure, Chronic