<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/NCT02191150</url>
  </required_header>
  <id_info>
    <org_study_id>20130300</org_study_id>
    <nct_id>NCT02191150</nct_id>
  </id_info>
  <brief_title>Study of Haemodialysis Patients Switching From Aranesp to Biosimilar</brief_title>
  <acronym>SHADE</acronym>
  <official_title>Retrospective Study of Stable Haemodialysis Patients Switched From Darbepoetin Alfa to Epoetin Alfa Biosimilar</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will obtain data to show insight into clinical outcomes of patients switching from&#xD;
      Darbepoetin Alfa to a epoetin alfa biosimilar.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Biosimilars were approved in 2007 by the EMA in EU and in 2010 by the TGA in Australia. This&#xD;
      study will look at the retrospective data of patients that have switched from Darbepoetin&#xD;
      Alfa to an approved epoetin alfa biosimilar. Data will be collected for the 26 week period&#xD;
      prior to switch and a 26 week period post switch to a biosimilar. Data to be collected&#xD;
      includes haemoglobin measurements, dose requirements, iron use, any transfusions,&#xD;
      hospitalisations and other lab values including TSAT, Ferritin and albumin. Data from the&#xD;
      study will be published.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Haemoglobin Concentration</measure>
    <time_frame>Duration of observation period -52 weeks</time_frame>
    <description>Mean haemoglobin concentration over time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ESA Doses</measure>
    <time_frame>Duration of observation period -52 weeks</time_frame>
    <description>Doses of ESA over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose ratio</measure>
    <time_frame>Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)</time_frame>
    <description>Dose ratio between the start of the post-switch observation period and pre-switch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose ratio</measure>
    <time_frame>Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)</time_frame>
    <description>Dose ratio between the end of the post-switch observation period and pre-switch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemoglobin excursions</measure>
    <time_frame>Duration of observation period -52 weeks</time_frame>
    <description>Haemoglobin excursions (&lt;10/dL and &gt;12g/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemglobin within range</measure>
    <time_frame>Duration of observation period -52 weeks</time_frame>
    <description>Haemoglobin in the range 10-12g/dL over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TSAT, ferritin and albumin values</measure>
    <time_frame>Duration of observation period -52 weeks</time_frame>
    <description>TSAT, ferritin and albumin over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron Use</measure>
    <time_frame>Duration of observation period -52 weeks</time_frame>
    <description>Iron use (dose/route) over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red cell transfusions (including number of units transfused)</measure>
    <time_frame>Duration of observation period -52 weeks</time_frame>
    <description>Red cell transfusions (including number of units transfused)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalisations (including primary cause)</measure>
    <time_frame>Duration of observation period -52 weeks</time_frame>
    <description>Hospitalisations (including primary cause)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Subjects with PRCA testing and incidence of neutralizing anti-erythropoietin antibodies</measure>
    <time_frame>Duration of 52-week observation period</time_frame>
    <description>Pure Red Cell Aplasia (PRCA) test and results</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">272</enrollment>
  <condition>Anaemia</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>Patients with CKD</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population comprises prevalent haemodialysis (HD) patients treated at EU and&#xD;
        Australian dialysis clinics after September 2008. Eligible patients will have received&#xD;
        treatment with darbepoetin alfa for at least 26 weeks prior to being converted to an&#xD;
        EMA/TGA-approved epoetin alfa biosimilar. At each participating study site, all potentially&#xD;
        eligible patients are to be considered for enrolment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Patients ≥18 years of age&#xD;
&#xD;
          -  Patients with CKD on haemodialysis and fulfilling the following:&#xD;
&#xD;
               -  Received HD for at least 26 weeks prior to switching from treatment with&#xD;
                  darbepoetin alfa to treatment with an EMA/TGA-approved epoetin alfa biosimilar&#xD;
&#xD;
               -  Received darbepoetin alfa treatment i.v. for at least 26 weeks immediately prior&#xD;
                  to switching to an EMA/TGA-approved epoetin alfa biosimilar (breaks due to&#xD;
                  treatment being intentionally withheld are permitted)&#xD;
&#xD;
               -  Switched from darbepoetin alfa treatment to an EMA/TGA-approved epoetin alfa&#xD;
                  biosimilar at least 26 weeks prior to enrolment&#xD;
&#xD;
               -  Received at least one dose of an EMA/TGA-approved epoetin alfa biosimilar after&#xD;
                  switching from darbepoetin alfa treatment&#xD;
&#xD;
          -  Mean monthly Hb 10-12g/dL in the 12 weeks prior to switch&#xD;
&#xD;
          -  Stable darbepoetin alfa dose (i.e. no more than one increment or decrement of PFS) in&#xD;
             the 12 weeks prior to switch&#xD;
&#xD;
          -  Patient or patient's legally acceptable representative has provided informed consent,&#xD;
             if applicable according to local requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with an ESA other than darbepoetin alfa during the 12 weeks prior to switch&#xD;
             to biosimilar&#xD;
&#xD;
          -  More than 14 days' cumulative treatment with short-acting ESA during weeks 26-13 prior&#xD;
             to switch to biosimilar&#xD;
&#xD;
          -  Subject received chemotherapy or major surgery during the 26 weeks prior to switch to&#xD;
             biosimilar&#xD;
&#xD;
          -  Subject was enrolled in an interventional device or drug study at any time during the&#xD;
             52-week data observation period or within 30 days prior to commencement of the data&#xD;
             observation period.&#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>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nambour</city>
        <state>Queensland</state>
        <zip>4560</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Burgas</city>
        <zip>8000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lemgo</city>
        <zip>32657</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lich</city>
        <zip>35423</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Minden</city>
        <zip>32429</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Egaleo, Athens</city>
        <zip>12244</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Egaleo</city>
        <zip>12242</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kallithea, Athens</city>
        <zip>17676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Larissa</city>
        <zip>41335</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Patra</city>
        <zip>26225</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Patra</city>
        <zip>26500</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Milazzo ME</city>
        <zip>98057</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pisa</city>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chojnice</city>
        <zip>89-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Krakow</city>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-954</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poznan</city>
        <zip>60-355</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rybnik</city>
        <zip>44-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jaen</city>
        <state>Andalucía</state>
        <zip>23007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zamora</city>
        <state>Castilla León</state>
        <zip>49022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Bulgaria</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>February 5, 2016</last_update_submitted>
  <last_update_submitted_qc>February 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anaemia, Chronic Kidney Disease, Switching, Aranesp, Darbepoetin Alfa, Epoetin Alfa Biosimilars, Haemodialysis.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</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/NCT02191150
org study id: 20130300
nct id: NCT02191150
lead sponsor: 
has dmc: No
The study will obtain data to show insight into clinical outcomes of patients switching from
      Darbepoetin Alfa to a epoetin alfa biosimilar.
Biosimilars were approved in 2007 by the EMA in EU and in 2010 by the TGA in Australia. This
      study will look at the retrospective data of patients that have switched from Darbepoetin
      Alfa to an approved epoetin alfa biosimilar. Data will be collected for the 26 week period
      prior to switch and a 26 week period post switch to a biosimilar. Data to be collected
      includes haemoglobin measurements, dose requirements, iron use, any transfusions,
      hospitalisations and other lab values including TSAT, Ferritin and albumin. Data from the
      study will be published.
time perspective: Retrospective
measure: Haemoglobin Concentration
time frame: Duration of observation period -52 weeks
description: Mean haemoglobin concentration over time
measure: ESA Doses
time frame: Duration of observation period -52 weeks
description: Doses of ESA over time.
measure: Dose ratio
time frame: Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)
description: Dose ratio between the start of the post-switch observation period and pre-switch
measure: Dose ratio
time frame: Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)
description: Dose ratio between the end of the post-switch observation period and pre-switch
measure: Haemoglobin excursions
time frame: Duration of observation period -52 weeks
description: Haemoglobin excursions (<10/dL and >12g/dL)
measure: Haemglobin within range
time frame: Duration of observation period -52 weeks
description: Haemoglobin in the range 10-12g/dL over time
measure: TSAT, ferritin and albumin values
time frame: Duration of observation period -52 weeks
description: TSAT, ferritin and albumin over time
measure: Iron Use
time frame: Duration of observation period -52 weeks
description: Iron use (dose/route) over time
measure: Red cell transfusions (including number of units transfused)
time frame: Duration of observation period -52 weeks
description: Red cell transfusions (including number of units transfused)
measure: Hospitalisations (including primary cause)
time frame: Duration of observation period -52 weeks
description: Hospitalisations (including primary cause)
measure: Number of Subjects with PRCA testing and incidence of neutralizing anti-erythropoietin antibodies
time frame: Duration of 52-week observation period
description: Pure Red Cell Aplasia (PRCA) test and results
arm group label: Cohort 1
description: Patients with CKD
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Australia
country: Bulgaria
country: Germany
country: Greece
country: Italy
country: Poland
country: Spain
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Anemia