<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/NCT03299244</url>
  </required_header>
  <id_info>
    <org_study_id>20150238</org_study_id>
    <nct_id>NCT03299244</nct_id>
  </id_info>
  <brief_title>Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)</brief_title>
  <official_title>A Multicenter, Multiple-dose, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet Hydrochloride With Intravenous Doses of Etelcalcetide (AMG 416) in Asian Hemodialysis Subjects With Secondary Hyperparathyroidism</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to demonstrate that treatment with etelcalcetide (AMG 416) is not&#xD;
      inferior to treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH)&#xD;
      levels by &gt; 30% from baseline among participants with chronic kidney disease (CKD) and&#xD;
      secondary hyperparathyroidism (SHPT) who require management with hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2018</start_date>
  <completion_date type="Actual">April 8, 2020</completion_date>
  <primary_completion_date type="Actual">April 8, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants will be randomized by Interactive Voice Response (IVR)/Interactive Web Response (IWR) in a 1:1 ratio to either three times per week (TIW) intravenous (IV) etelcalcetide (and daily oral placebo tablets) or daily oral cinacalcet tablets (and TIW IV placebo) in a double-blind, double-dummy manner. Treatment groups will be blinded to the investigator, participants, and the Amgen study team.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With &gt; 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis</measure>
    <time_frame>Baseline and the efficacy assessment phase (EAP; defined as weeks 20 to 27, inclusive).</time_frame>
    <description>Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With &gt; 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase</measure>
    <time_frame>Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive).</time_frame>
    <description>Predialysis intact parathyroid hormone levels were measured by a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With &gt; 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis</measure>
    <time_frame>Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive)</time_frame>
    <description>Predialysis intact parathyroid hormone levels were measured by a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase</measure>
    <time_frame>Baseline and the efficacy assessment phase (weeks 20 - 27, inclusive)</time_frame>
    <description>Predialysis corrected calcium was measured by a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase</measure>
    <time_frame>Efficacy assessment phase (weeks 20 - 27, inclusive)</time_frame>
    <description>Predialysis serum phosphorus was measured by a central laboratory.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With cCa &lt; 8.3 mg/dL At Any Time During the Study</measure>
    <time_frame>From first dose of study drug to end of study; up to 26 weeks + 30 days.</time_frame>
    <description>Corrected calcium was measured by the central laboratory.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With cCa &lt; 8.0 mg/dL At Any Time During the Study</measure>
    <time_frame>From first dose of study drug to end of study; up to 26 weeks + 30 days.</time_frame>
    <description>Corrected calcium was measured by the central laboratory.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With cCa &lt; 7.5 mg/dL At Any Time During the Study</measure>
    <time_frame>From first dose of study drug to end of study; up to 26 weeks + 30 days.</time_frame>
    <description>Corrected calcium was measured by the central laboratory.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study</measure>
    <time_frame>From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.</time_frame>
    <description>Common symptoms of hypocalcemia (diminished blood calcium) include paresthesias (fingertips, toes, or perioral), fatigue, muscle cramps, irritability or anxiety, tetany (eg, carpopedal spasm, laryngospasm), Chvostek's sign, seizures, and prolonged QT interval.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants Who Developed Antibodies to Etelcalcetide</measure>
    <time_frame>From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.</time_frame>
    <description>Developing antibody incidence is defined as participants who were binding antibody positive post-baseline with a negative or no result at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events</measure>
    <time_frame>From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence in a clinical study participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. The investigator assessed whether each adverse event was possibly related to study drug.&#xD;
A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria:&#xD;
fatal&#xD;
life threatening&#xD;
required in-patient hospitalization or prolongation of existing hospitalization&#xD;
resulted in persistent or significant disability/incapacity&#xD;
congenital anomaly/birth defect&#xD;
other medically important serious event</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">637</enrollment>
  <condition>Secondary Hyperparathyroidism</condition>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Cinacalcet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and the dose may have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum parathyroid hormone (PTH) ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etelcalcetide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and the dose may have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etelcalcetide</intervention_name>
    <description>Administered intravenously three times per week.</description>
    <arm_group_label>Etelcalcetide</arm_group_label>
    <other_name>AMG 416</other_name>
    <other_name>Parsabiv®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cinacalcet</intervention_name>
    <description>Cinacalcet administered orally once a day.</description>
    <arm_group_label>Cinacalcet</arm_group_label>
    <other_name>Sensipar®</other_name>
    <other_name>Mimpara®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has provided informed consent prior to performing any study-related&#xD;
             activities/procedures.&#xD;
&#xD;
          -  Male or female subjects ≥ 18 years of age or older at the time of signing informed&#xD;
             consent.&#xD;
&#xD;
          -  Subject must be receiving maintenance hemodialysis 3 times weekly for at least 3&#xD;
             months, with adequate hemodialysis based on a delivered measure of dialysis adequacy&#xD;
             (Kt/V) ≥ 1.2 or urea reduction ratio ≥ 65% within 4 weeks prior to screening&#xD;
             laboratory assessments. The Kt/V formula used for a subject must be the formula used&#xD;
             during routine care prior to screening.&#xD;
&#xD;
          -  Dialysate calcium concentration must be ≥ 2.5 mEq/L (1.25 mmol/L) and stable for at&#xD;
             least 4 weeks prior to screening laboratory assessments, and must remain ≥ 2.5 mEq/L&#xD;
             (1.25 mmol/L) for the duration of the study.&#xD;
&#xD;
          -  Subject must have SHPT as defined by one central laboratory screening predialysis&#xD;
             serum PTH value &gt; 500 pg/mL, within 2 weeks prior to randomization.&#xD;
&#xD;
          -  Subject currently receiving vitamin D sterols must have had no more than a maximum&#xD;
             dose change of 50% within the 4 weeks prior to screening laboratory assessments,&#xD;
             remain stable through randomization, and be expected to maintain stable doses for the&#xD;
             duration of the study, except for adjustments allowed per protocol or for safety&#xD;
             reasons.&#xD;
&#xD;
          -  Subject must have 1 screening predialysis serum cCa laboratory value ≥ 8.3 mg/dL&#xD;
             measured within 2 weeks prior to randomization.&#xD;
&#xD;
          -  A subject receiving calcium supplements must have had no more than a maximum dose&#xD;
             change of 50% within 2 weeks prior to screening laboratory assessments and remain&#xD;
             stable through randomization.&#xD;
&#xD;
          -  A subject receiving phosphate binders must have had no more than a maximum dose change&#xD;
             of 50% within the 2 weeks prior to screening laboratory assessments, remain stable&#xD;
             through randomization, and be expected to maintain stable dose for the duration of the&#xD;
             study, except for adjustments allowed per protocol or for safety reasons.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently receiving treatment in another investigational device or drug study, or ≤ 30&#xD;
             days since ending treatment on another investigational device or drug study(s). Other&#xD;
             investigational procedures while participating in this study are excluded.&#xD;
&#xD;
          -  Subject has received etelcalcetide in a prior clinical trial of etelcalcetide.&#xD;
&#xD;
          -  Subject has received cinacalcet during the 3 months prior to the first screening&#xD;
             laboratory assessments.&#xD;
&#xD;
          -  Subject has known sensitivity to any of the products or components of either&#xD;
             cinacalcet or etelcalcetide to be administered during dosing.&#xD;
&#xD;
          -  Subject has previously been randomized in this study.&#xD;
&#xD;
          -  Anticipated or scheduled parathyroidectomy during the study period.&#xD;
&#xD;
          -  Subject has received a parathyroidectomy within 6 months prior to dosing.&#xD;
&#xD;
          -  Anticipated or scheduled kidney transplant during the study period.&#xD;
&#xD;
          -  Subject has an unstable medical condition based on medical history, physical&#xD;
             examination, and routine laboratory tests, or is otherwise unstable in the judgment of&#xD;
             the Investigator.&#xD;
&#xD;
          -  Malignancy within the last 5 years of screening (except non-melanoma skin cancers or&#xD;
             cervical carcinoma in situ).&#xD;
&#xD;
          -  Grapefruit juice is prohibited.&#xD;
&#xD;
          -  Subject is pregnant or nursing, or planning to become pregnant or nurse during&#xD;
             treatment or within 3 months after the last dose of etelcalcetide or 30 days after the&#xD;
             last dose of cinacalcet&#xD;
&#xD;
          -  Female subject of childbearing potential who is unwilling to use an acceptable method&#xD;
             of effective contraception during treatment with investigational product (IP) through&#xD;
             3 months after the last dose of IP.&#xD;
&#xD;
          -  Subject has a history of symptomatic ventricular dysrhythmias or Torsades de Pointes.&#xD;
&#xD;
          -  Subject has a history of myocardial infarction, coronary angioplasty, or coronary&#xD;
             arterial bypass grafting within the past 6 months prior to screening.&#xD;
&#xD;
          -  Subject has clinically significant abnormalities on prestudy clinical examination or&#xD;
             abnormalities on the most recent central laboratory tests during the screening period&#xD;
             prior to randomization according to the Investigator including but not limited to the&#xD;
             following:&#xD;
&#xD;
               -  serum albumin &lt; 3.0 g/dL&#xD;
&#xD;
               -  serum magnesium &lt; 1.5 mg/dL&#xD;
&#xD;
               -  serum transaminase (alanine transaminase [ALT] or serum glutamic pyruvic&#xD;
                  transaminase [SGPT], aspartate aminotransferase [AST] or serum glutamic&#xD;
                  oxaloacetic transaminase [SGOT]) &gt; 3 times the upper limit of normal (ULN) at&#xD;
                  screening.&#xD;
&#xD;
          -  Subject likely not available to complete all protocol-required study visits or&#xD;
             procedures, and/or to comply with all required study procedures to the best of the&#xD;
             subject and Investigator's knowledge.&#xD;
&#xD;
          -  History or evidence of any other clinically significant disorder, condition or disease&#xD;
             (with the exception of those outlined above) that, in the opinion of the Investigator&#xD;
             or Amgen physician, if consulted, would pose a risk to subject safety or interfere&#xD;
             with the study evaluation, procedures or completion.&#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>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510150</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510180</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510630</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518035</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zhanjiang</city>
        <state>Guangdong</state>
        <zip>524001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changzhou</city>
        <state>Jiangsu</state>
        <zip>213003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wuxi</city>
        <state>Jiangsu</state>
        <zip>214023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116011</zip>
        <country>China</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116027</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110022</zip>
        <country>China</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Xian</city>
        <state>Shaanxi</state>
        <zip>710004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200090</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200240</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300121</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Urumqi</city>
        <state>Xinjiang</state>
        <zip>830054</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kowloon</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Territories</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110 017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110 025</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110 060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110 070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380 006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nadiad</city>
        <state>Gujarat</state>
        <zip>387 001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Belagavi</city>
        <state>Karnataka</state>
        <zip>590010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mysuru</city>
        <state>Karnataka</state>
        <zip>570001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kozhikode</city>
        <state>Kerala</state>
        <zip>673 004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kozhikode</city>
        <state>Kerala</state>
        <zip>673 008</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chandigarh</city>
        <state>Punjab</state>
        <zip>160 012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600 006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lucknow</city>
        <state>Uttar Pradesh</state>
        <zip>226 014</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dehradun</city>
        <state>Uttaranchal</state>
        <zip>248 001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wardha</city>
        <zip>442 004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Busan</city>
        <zip>602-715</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Busan</city>
        <zip>602-739</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Daegu</city>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gumi-si, Gyeongsangbuk-do</city>
        <zip>730-728</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guri-si, Gyeonggi-do</city>
        <zip>471-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>130-872</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>133-817</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>134-727</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>135-720</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>150-950</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>156-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>156-755</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ipoh</city>
        <state>Perak</state>
        <zip>30450</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>George Town</city>
        <state>Pinang</state>
        <zip>10990</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kuching</city>
        <state>Sarawak</state>
        <zip>93586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Batu Caves</city>
        <state>Selangor (incl. Putrajaya)</state>
        <zip>68100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changhua</city>
        <zip>50006</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Keelung</city>
        <zip>20401</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Taipei</city>
        <zip>23561</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taichung</city>
        <zip>40201</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tainan</city>
        <zip>70403</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tainan</city>
        <zip>71004</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <zip>10449</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <zip>11031</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <zip>11101</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taoyuan</city>
        <zip>33305</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Hong Kong</country>
    <country>India</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <results_first_submitted>April 5, 2021</results_first_submitted>
  <results_first_submitted_qc>April 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 30, 2021</results_first_posted>
  <last_update_submitted>April 5, 2021</last_update_submitted>
  <last_update_submitted_qc>April 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</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>Neoplasm Metastasis</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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>Cinacalcet</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.</ipd_access_criteria>
    <ipd_url>https://www.amgen.com/datasharing</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03299244/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03299244/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at 84 centers including mainland China (43 centers), Hong Kong (2 centers), India (12 centers), South Korea (11 centers), Malaysia (4 centers), and Taiwan (12 centers). Participants were enrolled from 15 May 2018 to 12 September 2019.</recruitment_details>
      <pre_assignment_details>Participants were randomized 1:1 to receive etelcalcetide or cinacalcet. Randomization was stratified by screening serum parathyroid hormone (PTH) level (&lt; 900 pg/mL, ≥ 900 pg/mL) (&lt; 95.40 pmol/L, ≥ 95.40 pmol/L), screening serum corrected calcium (cCa) measured by the central laboratory (≥ 9.0 mg/dL, &lt; 9.0 mg/dL) (≥ 2.25 mmol/L, &lt; 2.25 mmol/L), and country (China versus non-China).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cinacalcet</title>
          <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
        </group>
        <group group_id="P2">
          <title>Etelcalcetide</title>
          <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="317"/>
                <participants group_id="P2" count="320"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="315"/>
                <participants group_id="P2" count="318"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="270"/>
                <participants group_id="P2" count="282"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Decision by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The full analysis set includes all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Cinacalcet</title>
          <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
        </group>
        <group group_id="B2">
          <title>Etelcalcetide</title>
          <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="317"/>
            <count group_id="B2" value="320"/>
            <count group_id="B3" value="637"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.5" spread="12.9"/>
                    <measurement group_id="B2" value="52.2" spread="13.4"/>
                    <measurement group_id="B3" value="51.8" spread="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>18 - 64 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="264"/>
                    <measurement group_id="B2" value="262"/>
                    <measurement group_id="B3" value="526"/>
                  </measurement_list>
                </category>
                <category>
                  <title>65 - 74 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>75 - 84 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 85 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="138"/>
                    <measurement group_id="B2" value="142"/>
                    <measurement group_id="B3" value="280"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="179"/>
                    <measurement group_id="B2" value="178"/>
                    <measurement group_id="B3" value="357"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian Indian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Chinese</title>
                  <measurement_list>
                    <measurement group_id="B1" value="262"/>
                    <measurement group_id="B2" value="270"/>
                    <measurement group_id="B3" value="532"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stratification Factor: Screening Intact Parathyroid Hormone (iPTH)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 900 pg/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="131"/>
                    <measurement group_id="B3" value="259"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 900 pg/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="189"/>
                    <measurement group_id="B3" value="378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stratification Factor: Screening Corrected Calcium (cCa)</title>
          <description>When albumin was &lt; 4.0 g/dL (40 g/L), the calcium level was corrected according to the following formula:&#xD;
cCa (mg/dL) = total Ca (mg/dL) + (4 - albumin [g/dL]) x 0.8.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 9 mg/dL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="126"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 9 mg/dL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="255"/>
                    <measurement group_id="B2" value="256"/>
                    <measurement group_id="B3" value="511"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stratification Factor: Country/Region</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>China</title>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="191"/>
                    <measurement group_id="B3" value="380"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-China</title>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="129"/>
                    <measurement group_id="B3" value="257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intact Parathyroid Hormone Level</title>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1299.01" spread="830.99"/>
                    <measurement group_id="B2" value="1299.91" spread="853.82"/>
                    <measurement group_id="B3" value="1299.46" spread="841.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Corrected Calcium Level</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.71" spread="0.75"/>
                    <measurement group_id="B2" value="9.73" spread="0.90"/>
                    <measurement group_id="B3" value="9.72" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Phosphorus Level</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.67" spread="1.61"/>
                    <measurement group_id="B2" value="6.62" spread="1.55"/>
                    <measurement group_id="B3" value="6.64" spread="1.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Corrected Calcium Phosphorus Product (cCa x P)</title>
          <units>mg²/dL²</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.70" spread="16.39"/>
                    <measurement group_id="B2" value="64.41" spread="16.33"/>
                    <measurement group_id="B3" value="64.56" spread="16.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With &gt; 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis</title>
        <description>Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory.</description>
        <time_frame>Baseline and the efficacy assessment phase (EAP; defined as weeks 20 to 27, inclusive).</time_frame>
        <population>Full analysis set; participants with iPTH data during the EAP.</population>
        <group_list>
          <group group_id="O1">
            <title>Cinacalcet</title>
            <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
          <group group_id="O2">
            <title>Etelcalcetide</title>
            <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With &gt; 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis</title>
          <description>Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory.</description>
          <population>Full analysis set; participants with iPTH data during the EAP.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.2"/>
                    <measurement group_id="O2" value="71.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The analysis was conducted on the full analysis set (637 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.&#xD;
The Mantel-Haenszel estimator was used to calculate the treatment (Cinacalcet - Etelcalcetide), stratified by screening PTH level (&lt; 900 pg/mL, ≥ 900 pg/mL), screening serum cCa (&lt; 9.0 mg/dL, ≥ 9.0 mg/dL) measured by the central laboratory, and country (China versus non-China).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Etelcalcetide was considered non-inferior if the upper bound of the two-sided 95% confidence interval of the treatment difference (Cinacalcet - Etelcalcetide) was smaller than 12%, or if the lower bound of (Etelcalcetide - Cinacalcet) greater than -12%. If this criterion was met, the 2 key secondary endpoints were tested sequentially. If both key secondary endpoints were statistically significant, the other secondary endpoints were to be formally tested at an overall significance level of 0.05.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>4.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.05</ci_lower_limit>
            <ci_upper_limit>12.09</ci_upper_limit>
            <estimate_desc>Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With &gt; 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase</title>
        <description>Predialysis intact parathyroid hormone levels were measured by a central laboratory.</description>
        <time_frame>Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive).</time_frame>
        <population>Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (non-responder imputation).</population>
        <group_list>
          <group group_id="O1">
            <title>Cinacalcet</title>
            <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
          <group group_id="O2">
            <title>Etelcalcetide</title>
            <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With &gt; 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase</title>
          <description>Predialysis intact parathyroid hormone levels were measured by a central laboratory.</description>
          <population>Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (non-responder imputation).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="317"/>
                <count group_id="O2" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.6"/>
                    <measurement group_id="O2" value="59.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing of this key secondary efficacy endpoint at an overall significance level of 0.05 was to be performed if non-inferiority was demonstrated for the primary endpoint.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>CMH test stratified by screening iPTH level, screening cCa level, and country/region.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.47</ci_lower_limit>
            <ci_upper_limit>2.77</ci_upper_limit>
            <estimate_desc>Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With &gt; 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis</title>
        <description>Predialysis intact parathyroid hormone levels were measured by a central laboratory.</description>
        <time_frame>Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive)</time_frame>
        <population>Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP.</population>
        <group_list>
          <group group_id="O1">
            <title>Cinacalcet</title>
            <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
          <group group_id="O2">
            <title>Etelcalcetide</title>
            <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With &gt; 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis</title>
          <description>Predialysis intact parathyroid hormone levels were measured by a central laboratory.</description>
          <population>Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="317"/>
                <count group_id="O2" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.0"/>
                    <measurement group_id="O2" value="66.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Testing of this key secondary efficacy endpoint at an overall significance level of 0.05 was to be performed if non-inferiority was demonstrated for the primary endpoint, and superiority was demonstrated for the previous key secondary endpoint.</non_inferiority_desc>
            <p_value>0.033</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>CMH test stratified by screening iPTH level, screening cCa level, and country/region.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.03</ci_lower_limit>
            <ci_upper_limit>1.96</ci_upper_limit>
            <estimate_desc>Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase</title>
        <description>Predialysis corrected calcium was measured by a central laboratory.</description>
        <time_frame>Baseline and the efficacy assessment phase (weeks 20 - 27, inclusive)</time_frame>
        <population>Full analysis set; participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Cinacalcet</title>
            <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
          <group group_id="O2">
            <title>Etelcalcetide</title>
            <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase</title>
          <description>Predialysis corrected calcium was measured by a central laboratory.</description>
          <population>Full analysis set; participants with available data</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="277"/>
                <count group_id="O2" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.00" spread="0.50"/>
                    <measurement group_id="O2" value="-10.69" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed-effects Model Repeated Measures</method>
            <method_desc>Model includes treatment group, randomization stratification factors, study week, and study week by treatment as covariates.</method_desc>
            <param_type>Difference in Least Squares Means</param_type>
            <param_value>-2.82</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.67</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.14</ci_lower_limit>
            <ci_upper_limit>-1.50</ci_upper_limit>
            <estimate_desc>Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region. Standard error of the mean is the standard error of the least squares means difference.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase</title>
        <description>Predialysis serum phosphorus was measured by a central laboratory.</description>
        <time_frame>Efficacy assessment phase (weeks 20 - 27, inclusive)</time_frame>
        <population>Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Cinacalcet</title>
            <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
          <group group_id="O2">
            <title>Etelcalcetide</title>
            <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase</title>
          <description>Predialysis serum phosphorus was measured by a central laboratory.</description>
          <population>Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="317"/>
                <count group_id="O2" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2"/>
                    <measurement group_id="O2" value="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.41</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>CMH test stratified by screening iPTH level, screening cCa level, and country/region.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>1.65</ci_upper_limit>
            <estimate_desc>Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With cCa &lt; 8.3 mg/dL At Any Time During the Study</title>
        <description>Corrected calcium was measured by the central laboratory.</description>
        <time_frame>From first dose of study drug to end of study; up to 26 weeks + 30 days.</time_frame>
        <population>Participants in the safety analysis set with at least 1 post-baseline cCa value.&#xD;
The safety analysis set includes all randomized participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cinacalcet</title>
            <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
          <group group_id="O2">
            <title>Etelcalcetide</title>
            <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With cCa &lt; 8.3 mg/dL At Any Time During the Study</title>
          <description>Corrected calcium was measured by the central laboratory.</description>
          <population>Participants in the safety analysis set with at least 1 post-baseline cCa value.&#xD;
The safety analysis set includes all randomized participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="317"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="245"/>
                    <measurement group_id="O2" value="273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With cCa &lt; 8.0 mg/dL At Any Time During the Study</title>
        <description>Corrected calcium was measured by the central laboratory.</description>
        <time_frame>From first dose of study drug to end of study; up to 26 weeks + 30 days.</time_frame>
        <population>Participants in the safety analysis set with at least 1 post-baseline cCa value.</population>
        <group_list>
          <group group_id="O1">
            <title>Cinacalcet</title>
            <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
          <group group_id="O2">
            <title>Etelcalcetide</title>
            <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With cCa &lt; 8.0 mg/dL At Any Time During the Study</title>
          <description>Corrected calcium was measured by the central laboratory.</description>
          <population>Participants in the safety analysis set with at least 1 post-baseline cCa value.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="317"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="194"/>
                    <measurement group_id="O2" value="241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With cCa &lt; 7.5 mg/dL At Any Time During the Study</title>
        <description>Corrected calcium was measured by the central laboratory.</description>
        <time_frame>From first dose of study drug to end of study; up to 26 weeks + 30 days.</time_frame>
        <population>Participants in the safety analysis set with at least 1 post-baseline cCa value.</population>
        <group_list>
          <group group_id="O1">
            <title>Cinacalcet</title>
            <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
          <group group_id="O2">
            <title>Etelcalcetide</title>
            <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With cCa &lt; 7.5 mg/dL At Any Time During the Study</title>
          <description>Corrected calcium was measured by the central laboratory.</description>
          <population>Participants in the safety analysis set with at least 1 post-baseline cCa value.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="317"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study</title>
        <description>Common symptoms of hypocalcemia (diminished blood calcium) include paresthesias (fingertips, toes, or perioral), fatigue, muscle cramps, irritability or anxiety, tetany (eg, carpopedal spasm, laryngospasm), Chvostek's sign, seizures, and prolonged QT interval.</description>
        <time_frame>From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cinacalcet</title>
            <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
          <group group_id="O2">
            <title>Etelcalcetide</title>
            <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study</title>
          <description>Common symptoms of hypocalcemia (diminished blood calcium) include paresthesias (fingertips, toes, or perioral), fatigue, muscle cramps, irritability or anxiety, tetany (eg, carpopedal spasm, laryngospasm), Chvostek's sign, seizures, and prolonged QT interval.</description>
          <population>Safety analysis set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="318"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants Who Developed Antibodies to Etelcalcetide</title>
        <description>Developing antibody incidence is defined as participants who were binding antibody positive post-baseline with a negative or no result at baseline.</description>
        <time_frame>From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.</time_frame>
        <population>Safety analysis set participants assigned to etelcalcetide with a post-baseline antibody result.</population>
        <group_list>
          <group group_id="O1">
            <title>Etelcalcetide</title>
            <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Developed Antibodies to Etelcalcetide</title>
          <description>Developing antibody incidence is defined as participants who were binding antibody positive post-baseline with a negative or no result at baseline.</description>
          <population>Safety analysis set participants assigned to etelcalcetide with a post-baseline antibody result.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="307"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Treatment-emergent Adverse Events</title>
        <description>An adverse event is defined as any untoward medical occurrence in a clinical study participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. The investigator assessed whether each adverse event was possibly related to study drug.&#xD;
A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria:&#xD;
fatal&#xD;
life threatening&#xD;
required in-patient hospitalization or prolongation of existing hospitalization&#xD;
resulted in persistent or significant disability/incapacity&#xD;
congenital anomaly/birth defect&#xD;
other medically important serious event</description>
        <time_frame>From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cinacalcet</title>
            <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
          <group group_id="O2">
            <title>Etelcalcetide</title>
            <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events</title>
          <description>An adverse event is defined as any untoward medical occurrence in a clinical study participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. The investigator assessed whether each adverse event was possibly related to study drug.&#xD;
A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria:&#xD;
fatal&#xD;
life threatening&#xD;
required in-patient hospitalization or prolongation of existing hospitalization&#xD;
resulted in persistent or significant disability/incapacity&#xD;
congenital anomaly/birth defect&#xD;
other medically important serious event</description>
          <population>Safety analysis set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="318"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any treatment-emergent adverse event (TEAE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="303"/>
                    <measurement group_id="O2" value="306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs leading to discontinuation of study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatal adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="243"/>
                    <measurement group_id="O2" value="250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related serious adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related TEAEs leading to discontinuation of study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related fatal adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days).</time_frame>
      <desc>All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cinacalcet</title>
          <description>Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
        </group>
        <group group_id="E2">
          <title>Etelcalcetide</title>
          <description>Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="320"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Granulocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Microcytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Aortic valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Cardiovascular disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Hypertensive heart disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism secondary</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Complicated appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Febrile infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Infective aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Rectal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula occlusion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula site complication</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Coronary artery restenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Ilium fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Shunt malfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Vascular access complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Vascular access malfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Transplant evaluation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Fracture malunion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Jugular vein occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Speech disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Uraemic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Azotaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Jejunostomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Granulomatosis with polyangiitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Subclavian vein stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="293" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="294" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood calcium decreased</sub_title>
                <counts group_id="E1" subjects_affected="218" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="252" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Blood calcium increased</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Dialysis hypotension</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="318"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="318"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Amgen Inc.</organization>
      <phone>866-572-6436</phone>
      <email>medinfo@amgen.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03299244
org study id: 20150238
nct id: NCT03299244
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective is to demonstrate that treatment with etelcalcetide (AMG 416) is not
      inferior to treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH)
      levels by > 30% from baseline among participants with chronic kidney disease (CKD) and
      secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Participants will be randomized by Interactive Voice Response (IVR)/Interactive Web Response (IWR) in a 1:1 ratio to either three times per week (TIW) intravenous (IV) etelcalcetide (and daily oral placebo tablets) or daily oral cinacalcet tablets (and TIW IV placebo) in a double-blind, double-dummy manner. Treatment groups will be blinded to the investigator, participants, and the Amgen study team.
measure: Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis
time frame: Baseline and the efficacy assessment phase (EAP; defined as weeks 20 to 27, inclusive).
description: Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory.
measure: Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase
time frame: Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive).
description: Predialysis intact parathyroid hormone levels were measured by a central laboratory.
measure: Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis
time frame: Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive)
description: Predialysis intact parathyroid hormone levels were measured by a central laboratory.
measure: Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase
time frame: Baseline and the efficacy assessment phase (weeks 20 - 27, inclusive)
description: Predialysis corrected calcium was measured by a central laboratory.
measure: Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase
time frame: Efficacy assessment phase (weeks 20 - 27, inclusive)
description: Predialysis serum phosphorus was measured by a central laboratory.
measure: Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study
time frame: From first dose of study drug to end of study; up to 26 weeks + 30 days.
description: Corrected calcium was measured by the central laboratory.
measure: Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study
time frame: From first dose of study drug to end of study; up to 26 weeks + 30 days.
description: Corrected calcium was measured by the central laboratory.
measure: Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study
time frame: From first dose of study drug to end of study; up to 26 weeks + 30 days.
description: Corrected calcium was measured by the central laboratory.
measure: Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study
time frame: From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.
description: Common symptoms of hypocalcemia (diminished blood calcium) include paresthesias (fingertips, toes, or perioral), fatigue, muscle cramps, irritability or anxiety, tetany (eg, carpopedal spasm, laryngospasm), Chvostek's sign, seizures, and prolonged QT interval.
measure: Number of Participants Who Developed Antibodies to Etelcalcetide
time frame: From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.
description: Developing antibody incidence is defined as participants who were binding antibody positive post-baseline with a negative or no result at baseline.
measure: Number of Participants With Treatment-emergent Adverse Events
time frame: From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.
description: An adverse event is defined as any untoward medical occurrence in a clinical study participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. The investigator assessed whether each adverse event was possibly related to study drug.
A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria:
fatal
life threatening
required in-patient hospitalization or prolongation of existing hospitalization
resulted in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event
arm group label: Cinacalcet
arm group type: Active Comparator
description: Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and the dose may have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum parathyroid hormone (PTH) ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
arm group label: Etelcalcetide
arm group type: Experimental
description: Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and the dose may have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
intervention type: Drug
intervention name: Etelcalcetide
description: Administered intravenously three times per week.
arm group label: Etelcalcetide
other name: AMG 416
other name: Parsabiv®
intervention type: Drug
intervention name: Cinacalcet
description: Cinacalcet administered orally once a day.
arm group label: Cinacalcet
other name: Sensipar®
other name: Mimpara®
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: China
country: Hong Kong
country: India
country: Korea, Republic of
country: Malaysia
country: Taiwan
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Hyperparathyroidism
mesh term: Hyperparathyroidism, Secondary
mesh term: Cinacalcet
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
ipd url: https://www.amgen.com/datasharing
provided document: 
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reported events: 
certain agreements: 
point of contact: 