<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/NCT01725113</url>
  </required_header>
  <id_info>
    <org_study_id>12027</org_study_id>
    <nct_id>NCT01725113</nct_id>
  </id_info>
  <brief_title>Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol</brief_title>
  <acronym>ECRIP</acronym>
  <official_title>A Randomized, Prospective, Cross-Over Study of Calcitriol vs. Paricalcitol in the Treatment of Mineral and Bone Disease in Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Winthrop University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Winthrop University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this non-inferiority study is to compare the safety and effectiveness of a&#xD;
      mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol&#xD;
      in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO)&#xD;
      parathyroid hormone targets.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Active vitamin D analogs have been the mainstay of treatment for patients on hemodialysis&#xD;
      with mineral and bone disease (MBD) for the past decade. Intravenous calcitriol is an active&#xD;
      vitamin D analog which is nearly identical to natural 1, 25 Vitamin D3. Calcitriol results&#xD;
      from the hydroxylation of previtamin D3 in the liver and kidney. Paricalcitol, 19-nor-1 ,&#xD;
      25-dihydroxyvitamin D2, is a newer agent vitamin D analog. This agent is believed to have an&#xD;
      effect more specific to the parathyroid gland, and less specific to absorption of calcium and&#xD;
      phosphorus from the gut. Although both formulations appear equally effective in suppressing&#xD;
      parathyroid hormone (PTH), studies have suggested a greater calcemic effect with intravenous&#xD;
      calcitriol as compared to paricalcitol (1). Due to this, paricalcitol is the predominant&#xD;
      active vitamin D analog used in hemodialysis patients in the United States. Two recent&#xD;
      changes in the management of hemodialysis patients will likely reduce the amount of active&#xD;
      vitamin D analogs used in the near future: the liberalization of PTH goals according to&#xD;
      international guidelines, (2) and the implementation of bundled payments for dialysis by&#xD;
      Medicare. These changes challenge previous studies that have analyzed the safety and efficacy&#xD;
      of these medications. The purpose of this prospective, randomized, cross-over study will be&#xD;
      to determine whether calcitriol is as safe and effective as paricalcitol in the treatment of&#xD;
      MBD in hemodialysis patients using the revised KDIGO parathyroid hormone targets. Our&#xD;
      hypothesis is that calcitriol will be as equally safe and effective as paricalcitol in the&#xD;
      treatment of MBD in hemodialysis patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Nationwide shortage of study meds in 2013 loss of funding &amp; competing studies&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients in range for calcium during the 3 months after randomization and 3 months after cross-over.</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients in range for PTH during the 3 months after randomization and 3 months after cross-over.</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients in range for phosphorus during the 3 months after randomization and 3 months after cross-over.</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of active vitamin D analog used during the first 3months and 6 months of the study.</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Kidney Failure</condition>
  <condition>Secondary Hyperparathyroidism</condition>
  <condition>Hyperphosphatemia</condition>
  <condition>Hypercalcemia</condition>
  <arm_group>
    <arm_group_label>Calcitriol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be converted from paricalcitol to calcitriol according to published package inserts which describe a 10mcg:3mcg ratio.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paricalcitol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continuation of intravenous paricalcitol that patient was originally on at the time of recruitment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcitriol</intervention_name>
    <description>3 times weekly</description>
    <arm_group_label>Calcitriol</arm_group_label>
    <other_name>Calcijex®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paricalcitol</intervention_name>
    <description>3 times weekly</description>
    <arm_group_label>Paricalcitol</arm_group_label>
    <other_name>Zemplar®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All subjects will have been treated for at least three months on hemodialysis with IV&#xD;
        paricalcitol. These subjects must have a most recent calcium level within the normal range,&#xD;
        most recent phosphorus level &lt; 8 mg/dL and a most recent PTH between 130-585 pg/mL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if:&#xD;
&#xD;
          1. age greater than 18&#xD;
&#xD;
          2. active malignancy&#xD;
&#xD;
          3. expected survival greater than 6 months&#xD;
&#xD;
          4. high likelihood of renal transplant during the study period.&#xD;
&#xD;
          5. Low calcium bath&#xD;
&#xD;
          6. prior parathyroidectomy&#xD;
&#xD;
          7. use of calcimimetics&#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>Shayan Shirazian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Winthrop University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Winthrop University Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>January 11, 2016</last_update_submitted>
  <last_update_submitted_qc>January 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Hyperphosphatemia</mesh_term>
    <mesh_term>Hypercalcemia</mesh_term>
    <mesh_term>Hyperparathyroidism</mesh_term>
    <mesh_term>Hyperparathyroidism, Secondary</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcitriol</mesh_term>
  </intervention_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/NCT01725113
org study id: 12027
nct id: NCT01725113
lead sponsor: 
has dmc: No
The purpose of this non-inferiority study is to compare the safety and effectiveness of a
      mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol
      in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO)
      parathyroid hormone targets.
Active vitamin D analogs have been the mainstay of treatment for patients on hemodialysis
      with mineral and bone disease (MBD) for the past decade. Intravenous calcitriol is an active
      vitamin D analog which is nearly identical to natural 1, 25 Vitamin D3. Calcitriol results
      from the hydroxylation of previtamin D3 in the liver and kidney. Paricalcitol, 19-nor-1 ,
      25-dihydroxyvitamin D2, is a newer agent vitamin D analog. This agent is believed to have an
      effect more specific to the parathyroid gland, and less specific to absorption of calcium and
      phosphorus from the gut. Although both formulations appear equally effective in suppressing
      parathyroid hormone (PTH), studies have suggested a greater calcemic effect with intravenous
      calcitriol as compared to paricalcitol (1). Due to this, paricalcitol is the predominant
      active vitamin D analog used in hemodialysis patients in the United States. Two recent
      changes in the management of hemodialysis patients will likely reduce the amount of active
      vitamin D analogs used in the near future: the liberalization of PTH goals according to
      international guidelines, (2) and the implementation of bundled payments for dialysis by
      Medicare. These changes challenge previous studies that have analyzed the safety and efficacy
      of these medications. The purpose of this prospective, randomized, cross-over study will be
      to determine whether calcitriol is as safe and effective as paricalcitol in the treatment of
      MBD in hemodialysis patients using the revised KDIGO parathyroid hormone targets. Our
      hypothesis is that calcitriol will be as equally safe and effective as paricalcitol in the
      treatment of MBD in hemodialysis patients.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Percentage of patients in range for calcium during the 3 months after randomization and 3 months after cross-over.
time frame: 3 months
measure: Percentage of patients in range for PTH during the 3 months after randomization and 3 months after cross-over.
time frame: 3 months
measure: Percentage of patients in range for phosphorus during the 3 months after randomization and 3 months after cross-over.
time frame: 3 months
measure: Amount of active vitamin D analog used during the first 3months and 6 months of the study.
time frame: 3 months
arm group label: Calcitriol
arm group type: Experimental
description: Patients will be converted from paricalcitol to calcitriol according to published package inserts which describe a 10mcg:3mcg ratio.
arm group label: Paricalcitol
arm group type: Active Comparator
description: Continuation of intravenous paricalcitol that patient was originally on at the time of recruitment.
intervention type: Drug
intervention name: Calcitriol
description: 3 times weekly
arm group label: Calcitriol
other name: Calcijex®
intervention type: Drug
intervention name: Paricalcitol
description: 3 times weekly
arm group label: Paricalcitol
other name: Zemplar®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shayan Shirazian, MD
role: Principal Investigator
affiliation: Winthrop University Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bone Diseases
mesh term: Renal Insufficiency
mesh term: Hyperphosphatemia
mesh term: Hypercalcemia
mesh term: Hyperparathyroidism
mesh term: Hyperparathyroidism, Secondary
mesh term: Calcitriol