<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/NCT03787368</url>
  </required_header>
  <id_info>
    <org_study_id>20046</org_study_id>
    <secondary_id>2018-003109-24</secondary_id>
    <nct_id>NCT03787368</nct_id>
  </id_info>
  <brief_title>End-stage Renal Disease (ESRD) Pilot Study</brief_title>
  <official_title>An Observer-blind, Multi-center, Placebo-controlled, Parallel Group Study to Assess the Safety and Tolerability and to Characterize the Pharmacokinetics and the Pharmacodynamics of Different Doses of BAY1213790 in Patients With End-stage Renal Disease Undergoing Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the safety of two different doses of a drug&#xD;
      called BAY1213790 and how well it is tolerated in patients with end-stage renal disease&#xD;
      (ESRD) undergoing hemodialysis (HD). Approximately 40, with up to 60 study patients will take&#xD;
      part in the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">September 15, 2021</completion_date>
  <primary_completion_date type="Actual">September 15, 2021</primary_completion_date>
  <phase>Phase 1</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>Double (Participant, Investigator)</masking>
    <masking_description>Patients, investigators, and all other site staff will remain blinded for the administered BAY1213790 or placebo, with the exception of the unblinded pharmacist or specifically dedicated site personnel.The sponsor will be not be blinded. Bioanalysis of plasma concentrations and PD parameters, as well as the evaluation of results will be performed in a non-blinded fashion.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of major and CRNM bleeding events</measure>
    <time_frame>Approx. 4 weeks (Before study drug or placebo administration)</time_frame>
    <description>CRNM bleeding: Clinically Relevant Non-Major bleeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of major and CRNM bleeding events</measure>
    <time_frame>Approx. 4 weeks (After study drug or placebo administration)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) &gt;20% of AUC)</measure>
    <time_frame>Approx. 5 months (Pre-dose to follow up)</time_frame>
    <description>AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>aPTT will be measured via the kaolin-trigger method (clotting assay)</measure>
    <time_frame>Approx. 6 months (Before study drug or placebo administration to follow up)</time_frame>
    <description>aPTT: activated Partial Thromboplastin Time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factor XI activity will be assessed with an aPTT-based coagulation test using FXI</measure>
    <time_frame>Approx. 6 months (Before study drug or placebo administration to follow up)</time_frame>
    <description>FXI: Factor XI</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Renal Dialysis</condition>
  <arm_group>
    <arm_group_label>Dose 1 of BAY1213790</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intravenous infusion BAY1213790 (Dose 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 2 of BAY1213790</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intravenous infusion BAY1213790 (Dose 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single intravenous infusion placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY1213790</intervention_name>
    <description>Single intravenous infusion of BAY1213790 (Two different doses)</description>
    <arm_group_label>Dose 1 of BAY1213790</arm_group_label>
    <arm_group_label>Dose 2 of BAY1213790</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% sodium chloride solution</intervention_name>
    <description>Single intravenous infusion of Placebo (0.9% sodium chloride solution)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Male and female patients between 18 and 80 years of age.&#xD;
&#xD;
          -  ESRD on hemodialysis (including hemodiafiltration) for at least 3 months&#xD;
&#xD;
          -  Life expectancy of &gt; 6 months&#xD;
&#xD;
          -  Women of non-childbearing potential&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High risk for clinically significant bleeding&#xD;
&#xD;
          -  Acute renal failure&#xD;
&#xD;
          -  Planned major surgery in the next 7 months from randomization&#xD;
&#xD;
          -  Concomitant use of oral anticoagulant therapy or antiplatelet therapy&#xD;
&#xD;
          -  Documented thrombotic event in the past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>California Institute of Renal Research - Chula Vista</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Clinical Research, LLC</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research by Design, LLC</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60643</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal and Transplant Associates of New England, PC</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Charleroi Hôpital civil</name>
      <address>
        <city>Lodelinsart</city>
        <state>Hainaut</state>
        <zip>6042</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Bruxelles - Brussel</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHLO - Hospital Santa Cruz</name>
      <address>
        <city>Carnaxide</city>
        <state>Lisboa</state>
        <zip>2795-53</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pluribus Dialise - Cascais (DaVita)</name>
      <address>
        <city>Cascais</city>
        <state>Lisboa</state>
        <zip>2750-663</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHMT - Hospital Rainha Santa Isabel</name>
      <address>
        <city>Torres Novas</city>
        <state>Santarém</state>
        <zip>2350-754</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>A Coruña</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ciutat Sanitària i Universitària de Bellvitge</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Reina Sofía</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr. Peset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>End-stage renal disease patients undergoing hemodialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03787368
org study id: 20046
secondary id: 2018-003109-24
nct id: NCT03787368
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to investigate the safety of two different doses of a drug
      called BAY1213790 and how well it is tolerated in patients with end-stage renal disease
      (ESRD) undergoing hemodialysis (HD). Approximately 40, with up to 60 study patients will take
      part in the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Patients, investigators, and all other site staff will remain blinded for the administered BAY1213790 or placebo, with the exception of the unblinded pharmacist or specifically dedicated site personnel.The sponsor will be not be blinded. Bioanalysis of plasma concentrations and PD parameters, as well as the evaluation of results will be performed in a non-blinded fashion.
measure: Number of major and CRNM bleeding events
time frame: Approx. 4 weeks (Before study drug or placebo administration)
description: CRNM bleeding: Clinically Relevant Non-Major bleeding
measure: Number of major and CRNM bleeding events
time frame: Approx. 4 weeks (After study drug or placebo administration)
measure: AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)
time frame: Approx. 5 months (Pre-dose to follow up)
description: AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose
measure: aPTT will be measured via the kaolin-trigger method (clotting assay)
time frame: Approx. 6 months (Before study drug or placebo administration to follow up)
description: aPTT: activated Partial Thromboplastin Time
measure: Factor XI activity will be assessed with an aPTT-based coagulation test using FXI
time frame: Approx. 6 months (Before study drug or placebo administration to follow up)
description: FXI: Factor XI
arm group label: Dose 1 of BAY1213790
arm group type: Experimental
description: Single intravenous infusion BAY1213790 (Dose 1)
arm group label: Dose 2 of BAY1213790
arm group type: Experimental
description: Single intravenous infusion BAY1213790 (Dose 2)
arm group label: Placebo
arm group type: Placebo Comparator
description: Single intravenous infusion placebo
intervention type: Drug
intervention name: BAY1213790
description: Single intravenous infusion of BAY1213790 (Two different doses)
arm group label: Dose 1 of BAY1213790
arm group label: Dose 2 of BAY1213790
intervention type: Drug
intervention name: 0.9% sodium chloride solution
description: Single intravenous infusion of Placebo (0.9% sodium chloride solution)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
facility: 
facility: 
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country: Belgium
country: Portugal
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
sharing ipd: Undecided
ipd description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.