xml: <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/NCT05983770</url>
    </required_header>
    <id_info>
      <org_study_id>AT-1501-K207</org_study_id>
      <secondary_id>2023-503336-41-00</secondary_id>
      <secondary_id>U1111-1278-5225</secondary_id>
      <nct_id>NCT05983770</nct_id>
    </id_info>
    <brief_title>Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation</brief_title>
    <official_title>AT-1501-K207: BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eledon Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eledon Pharmaceuticals</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in&#xD;
        patients undergoing kidney transplantation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a randomized, multicenter, open-label, active control study to evaluate the&#xD;
        safety and efficacy of AT-1501 compared with tacrolimus in the prevention of rejection in&#xD;
        patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients&#xD;
        will receive rATG induction with corticosteroids (CS), and mycophenolate as maintenance&#xD;
        therapy, and will be randomized 1:1 to receive either AT-1501 or tacrolimus.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <phase>Phase 2</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>eGFR at 12 months</measure>
      <time_frame>Assessed from date of transplant through Day 364 (Month 12)</time_frame>
      <description>Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>NODAT at 12 months post-transplant</measure>
      <time_frame>Assessed from date of transplant through Day 364 (Month 12</time_frame>
      <description>The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of patient and graft survival at 12 months post-transplant</measure>
      <time_frame>Assessed from date of transplant through Day 364 (Month 12)</time_frame>
      <description>Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BPAR-free patient and graft survival at 12 months post-transplant</measure>
      <time_frame>The proportion of BPAR-free patient and graft survival at 12 months post-transplant</time_frame>
      <description>Assessed from date of transplant through Day 364 (Month 12)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BPAR at 12 months</measure>
      <time_frame>Assessed from date of transplant through Day 364 (Month 12)</time_frame>
      <description>The proportion of BPAR at 12 months</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Kidney Transplant Rejection</condition>
    <arm_group>
      <arm_group_label>Investigative</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>AT-1501 monoclonal antibody targeting CD40L given as an IV infusion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Comparator</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AT-1501</intervention_name>
      <description>IV infusions of AT-1501 20 mg/kg over 1 hour.</description>
      <arm_group_label>Investigative</arm_group_label>
      <other_name>Tegoprubart</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tacrolimus</intervention_name>
      <description>Tacrolimus will be administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter.</description>
      <arm_group_label>Comparator</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female ≥ 18 years of age&#xD;
  &#xD;
            2. Recipient of their first kidney transplant from a living or deceased donor&#xD;
  &#xD;
            3. Agree to comply with contraception requirements during and for at least 90 days after&#xD;
               the last administration of study drug&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Induction therapy, other than study assigned rATG, planned as part of initial&#xD;
               immunosuppressive regimen&#xD;
  &#xD;
            2. Currently treated with any systemic immunosuppressive regimen, including immunologic&#xD;
               biologic therapies&#xD;
  &#xD;
            3. Currently treated with corticosteroids other than topical or inhaled corticosteroids&#xD;
  &#xD;
            4. Will receive a kidney with an anticipated cold ischemia time of &gt; 30 hours&#xD;
  &#xD;
            5. Will receive a kidney from a donor that meets any of the following:&#xD;
  &#xD;
          5a. Donation after Cardiac Death (DCD) criteria; Or 5b. Kidney Donor Profile Index (KDPI)&#xD;
          of &gt; 85%; Or 5c. Is blood group (ABO) incompatible 6. Medical conditions that require&#xD;
          chronic use of systemic corticosteroids or other immunosuppressants 7. History of a&#xD;
          thromboembolic event, known hypercoagulable state, or condition requiring long term&#xD;
          anticoagulation 8. Positive T- or B-cell crossmatch that is due to HLA antibodies or&#xD;
          presence of a DSA at Screening&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Eledon Pharmaceuticals</last_name>
      <phone>949-238-8090</phone>
      <email>clinicaltrials@eledon.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Washington University in St. Louis</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63110</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Virginia Commonwealth University</name>
        <address>
          <city>Richmond</city>
          <state>Virginia</state>
          <zip>23298</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>AT-1501</keyword>
    <keyword>Kidney Transplant</keyword>
    <keyword>Renal Allograft Rejection</keyword>
    <keyword>Prophylaxis</keyword>
    <keyword>CD40L Inhibitor</keyword>
    <keyword>Humanized blocking antibody to CD40L</keyword>
    <keyword>Monoclonal Antibody</keyword>
    <keyword>Renal</keyword>
    <keyword>Transplant</keyword>
    <keyword>ESRD</keyword>
    <keyword>Tegoprubart</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tacrolimus</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983770
  org study id: AT-1501-K207
  secondary id: 2023-503336-41-00
  secondary id: U1111-1278-5225
  nct id: NCT05983770
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in
        patients undergoing kidney transplantation.
  This study is a randomized, multicenter, open-label, active control study to evaluate the
        safety and efficacy of AT-1501 compared with tacrolimus in the prevention of rejection in
        patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients
        will receive rATG induction with corticosteroids (CS), and mycophenolate as maintenance
        therapy, and will be randomized 1:1 to receive either AT-1501 or tacrolimus.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: eGFR at 12 months
  time frame: Assessed from date of transplant through Day 364 (Month 12)
  description: Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant
  measure: NODAT at 12 months post-transplant
  time frame: Assessed from date of transplant through Day 364 (Month 12
  description: The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant
  measure: The proportion of patient and graft survival at 12 months post-transplant
  time frame: Assessed from date of transplant through Day 364 (Month 12)
  description: Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis
  measure: BPAR-free patient and graft survival at 12 months post-transplant
  time frame: The proportion of BPAR-free patient and graft survival at 12 months post-transplant
  description: Assessed from date of transplant through Day 364 (Month 12)
  measure: BPAR at 12 months
  time frame: Assessed from date of transplant through Day 364 (Month 12)
  description: The proportion of BPAR at 12 months
  arm group label: Investigative
  arm group type: Experimental
  description: AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
  arm group label: Comparator
  arm group type: Active Comparator
  description: Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter
  intervention type: Drug
  intervention name: AT-1501
  description: IV infusions of AT-1501 20 mg/kg over 1 hour.
  arm group label: Investigative
  other name: Tegoprubart
  intervention type: Drug
  intervention name: Tacrolimus
  description: Tacrolimus will be administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter.
  arm group label: Comparator
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Eledon Pharmaceuticals
  phone: 949-238-8090
  email: clinicaltrials@eledon.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Tacrolimus
  sharing ipd: No