<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/NCT02185911</url>
  </required_header>
  <id_info>
    <org_study_id>20130301</org_study_id>
    <nct_id>NCT02185911</nct_id>
  </id_info>
  <brief_title>Observational Study of Correction of Anaemia With Darbepoetin Alfa at QM Dosing Interval in Patients With CKD Not on Dialysis</brief_title>
  <acronym>ADAPTATION</acronym>
  <official_title>Observational Study of Correction of Anaemia With Darbepoetin Alfa at Monthly Dose Frequency in EU and Australian Patients With Chronic Kidney Disease Not on Dialysis</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>
      To describe anaemia correction via haemoglobin measurements taken throughout observation&#xD;
      period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Darbepoetin alfa (Aranesp) is a long-acting ESA approved for treatment of anaemia in CKD&#xD;
      patients, and may be administered once a week (QW), once every two weeks (Q2W) or once a&#xD;
      month (QM) for correction and for maintenance in CKD patients not on dialysis. Prescribing&#xD;
      information for darbepoetin alfa was updated in August 2013 (in EU and Australia), to&#xD;
      incorporate the option for correction at QM dosing frequency in CKD patients not on dialysis.&#xD;
      There is very little published literature describing QM correction in a real-world setting.&#xD;
&#xD;
      Data obtained from this study are intended to contribute to filling a literature gap and to&#xD;
      provide a robust source of information for physicians.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">April 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>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Monthly Haemoglobin values</measure>
    <time_frame>During the 32 weeks post initiation of darbepoetin alfa QM</time_frame>
    <description>Monthly Hb within 10-12g/dL during the 32 weeks post initiation of darbepoetin alfa QM</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Doses of darbepoetin alfa/other ESAs over time</measure>
    <time_frame>Throughout the 46 week observation period</time_frame>
    <description>Doses of darbepoetin alfa/other ESAs over time (dose, route, frequency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemoglobin values</measure>
    <time_frame>Throughout the 46 week observation period</time_frame>
    <description>Haemoglobin over the observation period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Haemoglobin values</measure>
    <time_frame>Throughout the 46 week observation period</time_frame>
    <description>Change in haemoglobin from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase in haemoglobin from baseline</measure>
    <time_frame>Throughout the 46 week observation period</time_frame>
    <description>Increase in haemoglobin of at least 1g/dL from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemoglobin excursions</measure>
    <time_frame>Throughout the 46 week observation period</time_frame>
    <description>Haemoglobin excursions (&lt;10,&gt;12 g/dL) over the observation period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First haemoglobin within 10-12g/dL</measure>
    <time_frame>During the 32 weeks post initiation of darbepoetin alfa QM</time_frame>
    <description>Time from initiation of darbepoetin alfa QM to first haemoglobin within 10-12g/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>first dose frequency change after third dose of darbepoetin alfa QM</measure>
    <time_frame>During the 32 weeks post initiation of darbepoetin alfa QM</time_frame>
    <description>Time from third dose of darbepoetin alfa at QM dosing frequency to first frequency change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects remaining on darbepoetin alfa QM</measure>
    <time_frame>During the 32 weeks post initiation of darbepoetin alfa QM</time_frame>
    <description>Remaining on darbepoetin alfa QM for the full 32 weeks post initiation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TSAT, ferritin and albumin values</measure>
    <time_frame>Throughout the 46 week observation period</time_frame>
    <description>TSAT, ferritin and albumin over the observation period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron Use</measure>
    <time_frame>Throughout the 46 week observation period</time_frame>
    <description>Iron use (dose/route) over the observation period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusions</measure>
    <time_frame>Throughout the 46 week observation period</time_frame>
    <description>Transfusions over the observation period (number of tranfusions and the number of units transfused)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalisations</measure>
    <time_frame>Throughout the 46 week observation period</time_frame>
    <description>Hospitalisations (duration and primary cause) over the observation period</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">308</enrollment>
  <condition>Anaemia</condition>
  <condition>Chronic Kidney Disease (CKD)</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 CKD patients not on dialysis, ESA-naïve at time of&#xD;
        initiation of darbepoetin alfa QM, and treated at nephrology clinics in EU and Australia&#xD;
        from 01 May 2013. Eligible patients will have received at least three consecutive doses of&#xD;
        darbepoetin alfa for correction of anaemia at a QM dosing interval. At each participating&#xD;
        study site, all potentially elgible patients are to be considered for enrolment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients ≥18 years of age.&#xD;
&#xD;
          2. Patients with CKD:&#xD;
&#xD;
               1. Not on dialysis at time of darbepoetin alfa initiation at QM dosing frequency.&#xD;
&#xD;
               2. Hb &lt;10g/dL immediately prior to initiation of darbepoetin alfa at QM dosing.&#xD;
&#xD;
               3. Commenced darbepoetin alfa at QM dosing frequency during or after August 2013.&#xD;
&#xD;
               4. Received at least three consecutive doses of darbepoetin alfa at QM dosing&#xD;
                  frequency, being the initiation dose and two further doses at QM dosing&#xD;
                  frequency.&#xD;
&#xD;
          3. Patient or patient's legally acceptable representative has provided informed consent,&#xD;
             if applicable according to local requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treatment with an ESA within 14 weeks prior to initiation of darbepoetin alfa.&#xD;
&#xD;
          2. Patient was enrolled in an interventional device or drug study at any time during the&#xD;
             46-week data observation period or within 30 days prior to commencement of the data&#xD;
             observtion period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</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>Feldkirch</city>
        <zip>6807</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wien</city>
        <zip>1220</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dobrich</city>
        <zip>9300</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montana</city>
        <zip>3400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pazardjik</city>
        <zip>4400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4003</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <zip>1612</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Varna</city>
        <zip>9000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vratza</city>
        <zip>3000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Havlickuv Brod</city>
        <zip>580 22</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nove Mesto na Morave</city>
        <zip>592 31</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Trebic</city>
        <zip>674 35</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Athens</city>
        <zip>12462</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>Thessaloniki</city>
        <zip>54642</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Thessaloniki</city>
        <zip>56429</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baja</city>
        <zip>6500</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kecskemet</city>
        <zip>6000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szeged</city>
        <zip>6724</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szigetvar</city>
        <zip>7900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szombathely</city>
        <zip>9700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zalaegerszeg</city>
        <zip>8900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Albano Laziale RM</city>
        <zip>00041</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lodz</city>
        <zip>92-213</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lodz</city>
        <zip>93-338</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-718</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>Sieradz</city>
        <zip>98-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stalowa Wola</city>
        <zip>37-450</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cordoba</city>
        <state>Andalucía</state>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Badalona</city>
        <state>Cataluña</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Valencia</city>
        <state>Comunidad Valenciana</state>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Valencia</city>
        <state>Comunidad Valenciana</state>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Bulgaria</country>
    <country>Czech Republic</country>
    <country>Greece</country>
    <country>Hungary</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>March 2016</verification_date>
  <study_first_submitted>June 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>March 4, 2016</last_update_submitted>
  <last_update_submitted_qc>March 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chronic kidney disease,</keyword>
  <keyword>anaemia correction/maintenance,</keyword>
  <keyword>non dialysis,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <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/NCT02185911
org study id: 20130301
nct id: NCT02185911
lead sponsor: 
has dmc: No
To describe anaemia correction via haemoglobin measurements taken throughout observation
      period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM
Darbepoetin alfa (Aranesp) is a long-acting ESA approved for treatment of anaemia in CKD
      patients, and may be administered once a week (QW), once every two weeks (Q2W) or once a
      month (QM) for correction and for maintenance in CKD patients not on dialysis. Prescribing
      information for darbepoetin alfa was updated in August 2013 (in EU and Australia), to
      incorporate the option for correction at QM dosing frequency in CKD patients not on dialysis.
      There is very little published literature describing QM correction in a real-world setting.

      Data obtained from this study are intended to contribute to filling a literature gap and to
      provide a robust source of information for physicians.
observational model: Cohort
measure: Monthly Haemoglobin values
time frame: During the 32 weeks post initiation of darbepoetin alfa QM
description: Monthly Hb within 10-12g/dL during the 32 weeks post initiation of darbepoetin alfa QM
measure: Doses of darbepoetin alfa/other ESAs over time
time frame: Throughout the 46 week observation period
description: Doses of darbepoetin alfa/other ESAs over time (dose, route, frequency)
measure: Haemoglobin values
time frame: Throughout the 46 week observation period
description: Haemoglobin over the observation period
measure: Change in Haemoglobin values
time frame: Throughout the 46 week observation period
description: Change in haemoglobin from baseline
measure: Increase in haemoglobin from baseline
time frame: Throughout the 46 week observation period
description: Increase in haemoglobin of at least 1g/dL from baseline
measure: Haemoglobin excursions
time frame: Throughout the 46 week observation period
description: Haemoglobin excursions (<10,>12 g/dL) over the observation period
measure: First haemoglobin within 10-12g/dL
time frame: During the 32 weeks post initiation of darbepoetin alfa QM
description: Time from initiation of darbepoetin alfa QM to first haemoglobin within 10-12g/dL
measure: first dose frequency change after third dose of darbepoetin alfa QM
time frame: During the 32 weeks post initiation of darbepoetin alfa QM
description: Time from third dose of darbepoetin alfa at QM dosing frequency to first frequency change
measure: Subjects remaining on darbepoetin alfa QM
time frame: During the 32 weeks post initiation of darbepoetin alfa QM
description: Remaining on darbepoetin alfa QM for the full 32 weeks post initiation
measure: TSAT, ferritin and albumin values
time frame: Throughout the 46 week observation period
description: TSAT, ferritin and albumin over the observation period
measure: Iron Use
time frame: Throughout the 46 week observation period
description: Iron use (dose/route) over the observation period
measure: Transfusions
time frame: Throughout the 46 week observation period
description: Transfusions over the observation period (number of tranfusions and the number of units transfused)
measure: Hospitalisations
time frame: Throughout the 46 week observation period
description: Hospitalisations (duration and primary cause) over the observation period
arm group label: Cohort 1
description: Patients with CKD
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Austria
country: Bulgaria
country: Czech Republic
country: Greece
country: Hungary
country: Italy
country: Poland
country: Spain
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia