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/NCT06021457</url>
    </required_header>
    <id_info>
      <org_study_id>REN-007</org_study_id>
      <nct_id>NCT06021457</nct_id>
    </id_info>
    <brief_title>Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery</brief_title>
    <official_title>A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Renibus Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Renibus Therapeutics, Inc.</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>
        The purpose of this study is to evaluate the effect of RBT-1 on reducing the risk of&#xD;
        post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass&#xD;
        (CPB).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</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>
      <intervention_model_description>Subjects will be randomized 1:1 to RBT-1 or placebo</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, days in ICU, and 30-day</measure>
      <time_frame>Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable</time_frame>
      <description>The analysis will be based on a &quot;win ratio,&quot; which uses the Finkelstein-Schoenfeld method wherein all RBT-1 patients are paired with all placebo patients; each pair is declared to be a win for RBT-1, a win for placebo, or a tie, based on the hierarchical composite. The win ratio is the ratio of the number of wins for RBT-1 divided by the number of wins for placebo.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Composite of the Number of Post-operative Complications</measure>
      <time_frame>Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable</time_frame>
      <description>The number of the following post-operative complications per patient will be assessed:&#xD;
  Death&#xD;
  AKI requiring dialysis&#xD;
  &gt;3 days in ICU&#xD;
  &gt;24 hours on ventilator&#xD;
  30-day cardiopulmonary readmission&#xD;
  Need for blood transfusion during index hospitalization&#xD;
  New-onset atrial fibrillation during index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU Days</measure>
      <time_frame>Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days)</time_frame>
      <description>Days in ICU</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>30-day Cardiopulmonary Readmission Rates</measure>
      <time_frame>Within 30-days post-discharge</time_frame>
      <description>Readmissions due to cardiopulmonary reasons</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Post-Operative Complications in Cardiac Surgery</condition>
    <arm_group>
      <arm_group_label>RBT-1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single IV infusion prior to cardiac surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Single IV infusion prior to cardiac surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>RBT-1</intervention_name>
      <description>Intravenous administration</description>
      <arm_group_label>RBT-1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Intravenous administration</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female, ≥18 years of age at Screening.&#xD;
  &#xD;
            2. Planned to undergo non-emergent CABG and/or cardiac valve surgery requiring CPB;&#xD;
               non-emergent surgery must allow for study drug infusion ≥24 but ≤48 hours prior to&#xD;
               surgery.&#xD;
  &#xD;
            3. If female, subjects must use an effective method of birth control or abstain from&#xD;
               sexual relations with a male partner (unless has undergone tubal ligation or&#xD;
               hysterectomy or is at least 1 year postmenopausal) for the duration of their study&#xD;
               participation.&#xD;
  &#xD;
            4. If male, subjects must use an effective method of birth control or abstain from sexual&#xD;
               relations with a female partner for the duration of their study participation, unless&#xD;
               the subject has had a vasectomy ≥6 months prior to infusion with study drug.&#xD;
  &#xD;
            5. Willingness to comply with all study-related procedures and assessments.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Surgery planned to occur &lt;24 hours from the start of study drug infusion.&#xD;
  &#xD;
            2. Presence of acute organ dysfunction (AKI, acute decompensated heart failure, acute&#xD;
               respiratory failure, stroke, etc) as assessed by the Investigator at the time of&#xD;
               Screening.&#xD;
  &#xD;
            3. Surgery to be performed without CPB.&#xD;
  &#xD;
            4. Chronic kidney disease (CKD) requiring dialysis.&#xD;
  &#xD;
            5. Hypokalemia and/or hypomagnesemia within 24 hours prior to study drug infusion;&#xD;
               electrolytes can be replenished if low.&#xD;
  &#xD;
            6. Cardiogenic shock or requirement for inotropes, vasopressors, or other mechanical&#xD;
               devices, such as intra-aortic balloon pump (IABP).&#xD;
  &#xD;
            7. Known history of cancer within the past 2 years, except for carcinoma in situ of the&#xD;
               cervix or breast, early-stage prostate cancer, or adequately treated non-melanoma&#xD;
               cancer of the skin.&#xD;
  &#xD;
            8. Known or suspected sepsis at time of Screening.&#xD;
  &#xD;
            9. Asplenia (anatomic or functional).&#xD;
  &#xD;
           10. History of hemochromatosis, iron overload, or porphyria.&#xD;
  &#xD;
           11. Known hypersensitivity or previous anaphylaxis to SnPP or FeS.&#xD;
  &#xD;
           12. Female subject who is pregnant or breastfeeding.&#xD;
  &#xD;
           13. Participation in a study involving an investigational drug or device within 30 days&#xD;
               prior to study drug infusion.&#xD;
  &#xD;
           14. In the opinion of the Investigator, for any reason, the subject is an unsuitable&#xD;
               candidate to receive RBT-1.&#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>Andre Lamy, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>World Health Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ayla Rasmussen</last_name>
      <phone>443-569-9228</phone>
      <email>arasmussen@renibus.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cardiac Surgery</keyword>
    <keyword>CABG</keyword>
    <keyword>Valve</keyword>
    <keyword>Cardiopulmonary Bypass</keyword>
    <keyword>Preconditioning</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Postoperative Complications</mesh_term>
    </condition_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/NCT06021457
  org study id: REN-007
  nct id: NCT06021457
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the effect of RBT-1 on reducing the risk of
        post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass
        (CPB).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Subjects will be randomized 1:1 to RBT-1 or placebo
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, days in ICU, and 30-day
  time frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable
  description: The analysis will be based on a "win ratio," which uses the Finkelstein-Schoenfeld method wherein all RBT-1 patients are paired with all placebo patients; each pair is declared to be a win for RBT-1, a win for placebo, or a tie, based on the hierarchical composite. The win ratio is the ratio of the number of wins for RBT-1 divided by the number of wins for placebo.
  measure: Composite of the Number of Post-operative Complications
  time frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable
  description: The number of the following post-operative complications per patient will be assessed:
  Death
  AKI requiring dialysis
  >3 days in ICU
  >24 hours on ventilator
  30-day cardiopulmonary readmission
  Need for blood transfusion during index hospitalization
  New-onset atrial fibrillation during index hospitalization
  measure: ICU Days
  time frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days)
  description: Days in ICU
  measure: 30-day Cardiopulmonary Readmission Rates
  time frame: Within 30-days post-discharge
  description: Readmissions due to cardiopulmonary reasons
  arm group label: RBT-1
  arm group type: Experimental
  description: Single IV infusion prior to cardiac surgery
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Single IV infusion prior to cardiac surgery
  intervention type: Drug
  intervention name: RBT-1
  description: Intravenous administration
  arm group label: RBT-1
  intervention type: Drug
  intervention name: Placebo
  description: Intravenous administration
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Andre Lamy, MD
  role: Principal Investigator
  affiliation: World Health Research Institute
  last name: Ayla Rasmussen
  phone: 443-569-9228
  email: arasmussen@renibus.com
  responsible party type: Sponsor
  mesh term: Postoperative Complications
  sharing ipd: No