<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/NCT03023748</url>
  </required_header>
  <id_info>
    <org_study_id>UW11-293</org_study_id>
    <nct_id>NCT03023748</nct_id>
  </id_info>
  <brief_title>Intravenous Paricalcitol in Chronic Hemodialysis Patients</brief_title>
  <official_title>Providing Intravenous Paricalcitol Treatment to the Sick and Poor Chronic Hemodialysis Patients With Severe Secondary Hyperparathyroidism Resistant to Existing Vitamin D Analogs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to provide intravenous paritcalcitol treatment for the sick and poor&#xD;
      hemodialysis patients with severe secondary hyperparathyroidism (SHPT) resistant to existing&#xD;
      vitamin D analogs therapy or with hypercalcemia precluding the use of existing vitamin D&#xD;
      analogs.&#xD;
&#xD;
      The study aims to evaluate the effect of paricalcitol on control of SHPT, biochemical&#xD;
      parameters of chronic kidney disease-mineral bone disease, cardiac parameters, vascular&#xD;
      calcification and stiffness parameters and nutrition status in patients receiving chronic&#xD;
      hemodialysis treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 2-year single-arm intervention study of which intravenous paricalcitol will be&#xD;
      provided as a second-line treatment to 30 chronic hemodialysis patients with severe SHPT&#xD;
      (defined as intact parathyroid hormone [iPTH] ≥ 800pg/mL) resistant to existing vitamin D&#xD;
      analogs treatment (including rocaltrol and alfacalcidol) or with hypercalcemia (defined as&#xD;
      serum calcium ≥2.56mmol/L) precluding the use of existing vitamin D analogs.&#xD;
&#xD;
      The study aims to evaluate the control of SHPT, various biochemical parameters of chronic&#xD;
      kidney disease-mineral bone disease, left ventricular mass and volumes, vascular&#xD;
      calcification and stiffness parameters, handgrip strength and serum albumin with the use of&#xD;
      intravenous paricalcitol in patients receiving chronic hemodialysis treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2011</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in left ventricular mass index</measure>
    <time_frame>52 weeks and 104 weeks</time_frame>
    <description>MRI determined cardiac parameters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Coronary artery calcium score</measure>
    <time_frame>52 and 104 weeks</time_frame>
    <description>Computed tomography determined coronary artery calcium score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Aortic stiffness</measure>
    <time_frame>52 and 104 weeks</time_frame>
    <description>aortic pulse wave velocity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in handgrip strength</measure>
    <time_frame>52 and 104 weeks</time_frame>
    <description>nutrition and functional parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Serum albumin</measure>
    <time_frame>52 and 104 weeks</time_frame>
    <description>Nutrition parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum Calcium and phosphate</measure>
    <time_frame>52 and 104 weeks</time_frame>
    <description>Biochemical parameters of CKD-MBD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intact parathyroid hormone</measure>
    <time_frame>52 and 104 weeks</time_frame>
    <description>Biochemical parameters of CKD-MBD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in alkaline phosphatase</measure>
    <time_frame>52 and 104 weeks</time_frame>
    <description>biochemical parameters of CKD-MBD</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Endstage Renal Disease</condition>
  <condition>Secondary Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>intravenous paricalcitol solutions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous paricalcitol will be administered twice or thrice weekly post-hemodialysis with a dose based on the baseline iPTH level divided by 120.&#xD;
For instance, with a baseline iPTH 1200pg/mL, an induction dose of 10mcg twice or thrice weekly will be given. The maximum weekly dose allowed is 30mcg. Subsequent dose titration may be required depending on the serum PTH level. Intravenous paricalcitol will be continued up to 24 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Paricalcitol</intervention_name>
    <description>Twenty four months of intravenous paricalcitol will be given twice or thrice weekly post-hemodialysis depending on frequency of hemodialysis of the patients</description>
    <arm_group_label>intravenous paricalcitol solutions</arm_group_label>
    <other_name>Zemplar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic hemodialysis patients with severe SHPT (defined as iPTH ≥ 800pg/mL) resistant&#xD;
             to rocaltrol or alfacalcidol (defined as iPTH not controlled in the range between 2 -&#xD;
             9 times of lab upper limit reference).&#xD;
&#xD;
          -  Chronic hemodialysis patients with severe SHPT and at the same time hypercalcemia&#xD;
             (defined as serum calcium ≥2.56mmol/L) but still &lt; 2.8mmol/L precluding the use of&#xD;
             rocaltrol or alfacalcidol but still feasible to use paricalcitol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic malignancy,&#xD;
&#xD;
          -  Patients with extremely poor general condition (eg. bedbound) and expected lifespan is&#xD;
             below 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angela YM Wang, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Mary Hospital and Tung Wah Hospital</name>
      <address>
        <city>Hong Kong</city>
        <zip>0000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 7, 2017</study_first_submitted>
  <study_first_submitted_qc>January 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 14, 2017</last_update_submitted>
  <last_update_submitted_qc>January 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Angela Yee-Moon Wang</investigator_full_name>
    <investigator_title>Honorary Associate Professor</investigator_title>
  </responsible_party>
  <keyword>activated vitamin D treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Hyperparathyroidism</mesh_term>
    <mesh_term>Hyperparathyroidism, Secondary</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/NCT03023748
org study id: UW11-293
nct id: NCT03023748
lead sponsor: 
collaborator: 
has dmc: Yes
This study aims to provide intravenous paritcalcitol treatment for the sick and poor
      hemodialysis patients with severe secondary hyperparathyroidism (SHPT) resistant to existing
      vitamin D analogs therapy or with hypercalcemia precluding the use of existing vitamin D
      analogs.

      The study aims to evaluate the effect of paricalcitol on control of SHPT, biochemical
      parameters of chronic kidney disease-mineral bone disease, cardiac parameters, vascular
      calcification and stiffness parameters and nutrition status in patients receiving chronic
      hemodialysis treatment.
This is a 2-year single-arm intervention study of which intravenous paricalcitol will be
      provided as a second-line treatment to 30 chronic hemodialysis patients with severe SHPT
      (defined as intact parathyroid hormone [iPTH] ≥ 800pg/mL) resistant to existing vitamin D
      analogs treatment (including rocaltrol and alfacalcidol) or with hypercalcemia (defined as
      serum calcium ≥2.56mmol/L) precluding the use of existing vitamin D analogs.

      The study aims to evaluate the control of SHPT, various biochemical parameters of chronic
      kidney disease-mineral bone disease, left ventricular mass and volumes, vascular
      calcification and stiffness parameters, handgrip strength and serum albumin with the use of
      intravenous paricalcitol in patients receiving chronic hemodialysis treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in left ventricular mass index
time frame: 52 weeks and 104 weeks
description: MRI determined cardiac parameters
measure: Change in Coronary artery calcium score
time frame: 52 and 104 weeks
description: Computed tomography determined coronary artery calcium score
measure: Change in Aortic stiffness
time frame: 52 and 104 weeks
description: aortic pulse wave velocity
measure: Change in handgrip strength
time frame: 52 and 104 weeks
description: nutrition and functional parameters
measure: Change in Serum albumin
time frame: 52 and 104 weeks
description: Nutrition parameters
measure: Change in serum Calcium and phosphate
time frame: 52 and 104 weeks
description: Biochemical parameters of CKD-MBD
measure: Change in Intact parathyroid hormone
time frame: 52 and 104 weeks
description: Biochemical parameters of CKD-MBD
measure: Change in alkaline phosphatase
time frame: 52 and 104 weeks
description: biochemical parameters of CKD-MBD
arm group label: intravenous paricalcitol solutions
arm group type: Experimental
description: Intravenous paricalcitol will be administered twice or thrice weekly post-hemodialysis with a dose based on the baseline iPTH level divided by 120.
For instance, with a baseline iPTH 1200pg/mL, an induction dose of 10mcg twice or thrice weekly will be given. The maximum weekly dose allowed is 30mcg. Subsequent dose titration may be required depending on the serum PTH level. Intravenous paricalcitol will be continued up to 24 months.
intervention type: Drug
intervention name: Intravenous Paricalcitol
description: Twenty four months of intravenous paricalcitol will be given twice or thrice weekly post-hemodialysis depending on frequency of hemodialysis of the patients
arm group label: intravenous paricalcitol solutions
other name: Zemplar
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Angela YM Wang, MD PhD
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Angela Yee-Moon Wang
investigator title: Honorary Associate Professor
mesh term: Neoplasm Metastasis
mesh term: Kidney Failure, Chronic
mesh term: Hyperparathyroidism
mesh term: Hyperparathyroidism, Secondary
sharing ipd: No