<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/NCT03810417</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00083553</org_study_id>
    <nct_id>NCT03810417</nct_id>
  </id_info>
  <brief_title>Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI</brief_title>
  <official_title>Single System Double Blinded Trial to Evaluate the Effect of Pre-operative Treatment With DigiFab to Prevent Post-operative Acute Kidney Injury (AKI) in Patients at High Risk for AKI Undergoing Cardiac Bypass Graft Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute kidney injury (AKI) occurs in up to 30% of patients undergoing coronary artery bypass&#xD;
      graft (CABG) surgery, and often requires patients to go on dialysis. In patients needing&#xD;
      dialysis, the risk of dying is very high.There are no known therapies to reduce the chance of&#xD;
      developing kidney damage after heart surgery. There is evidence that patients with high&#xD;
      levels of a substance called ouabain have an increased risk of developing kidney damage. This&#xD;
      study is testing the hypothesis that giving a medication called DigiFab to lower the ouabain&#xD;
      levels will reduce the risk of developing kidney damage after heart surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized double-blinded study investigating the role of DigiFab in patients with&#xD;
      elevated risk of acute kidney injury undergoing CABG surgery. University of Maryland Medical&#xD;
      Center (UMMC) and University of Maryland St Joseph Medical Center (UMSJMC) patients who are&#xD;
      undergoing CABG, meet the inclusion criteria and provide consent will be enrolled in this&#xD;
      study and randomized to either DigiFab arm or the placebo (vehicle) arm. The study involves a&#xD;
      follow up period of 72 hours post CABG surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 22, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 4</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>Patients undergoing coronary artery bypass surgery</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigational pharmacy will provide active drug or placebo</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Renal function</measure>
    <time_frame>72 hours</time_frame>
    <description>Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Need for dialysis</measure>
    <time_frame>30 days</time_frame>
    <description>Number of patients with any dialysis given within 30 days of surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Digifab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Digifab intravenous</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>saline intravenous</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Digoxin Antibodies Fab Fragments</intervention_name>
    <description>Digoxin antibodies</description>
    <arm_group_label>Digifab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing coronary artery bypass surgery&#xD;
&#xD;
          -  glomerular filtration rate &gt; 15 History of Diabetes Mellitus or GFR &lt; 60&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to Digifab Contrast dye within 3 days Creatinine &gt; 25% above baseline&#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>Stephen S Gottlieb</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephen Gottlieb, MD</last_name>
    <phone>4103288788</phone>
    <email>sgottlie@medicine.umaryland.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen Gottlieb, MD</last_name>
      <phone>410-328-8788</phone>
      <email>sgottlie@medicine.umaryland.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>St Josephs Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Stephen Gottlieb</last_name>
      <phone>410-328-8788</phone>
      <email>sgottlie@medicine.umaryland.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Stephen Gottlieb</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>coronary artery bypass surgery</keyword>
  <keyword>ouabain</keyword>
  <keyword>acute kidney injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digoxin</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulin Fab Fragments</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03810417
org study id: HP-00083553
nct id: NCT03810417
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Acute kidney injury (AKI) occurs in up to 30% of patients undergoing coronary artery bypass
      graft (CABG) surgery, and often requires patients to go on dialysis. In patients needing
      dialysis, the risk of dying is very high.There are no known therapies to reduce the chance of
      developing kidney damage after heart surgery. There is evidence that patients with high
      levels of a substance called ouabain have an increased risk of developing kidney damage. This
      study is testing the hypothesis that giving a medication called DigiFab to lower the ouabain
      levels will reduce the risk of developing kidney damage after heart surgery.
This is a randomized double-blinded study investigating the role of DigiFab in patients with
      elevated risk of acute kidney injury undergoing CABG surgery. University of Maryland Medical
      Center (UMMC) and University of Maryland St Joseph Medical Center (UMSJMC) patients who are
      undergoing CABG, meet the inclusion criteria and provide consent will be enrolled in this
      study and randomized to either DigiFab arm or the placebo (vehicle) arm. The study involves a
      follow up period of 72 hours post CABG surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients undergoing coronary artery bypass surgery
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Investigational pharmacy will provide active drug or placebo
measure: Renal function
time frame: 72 hours
description: Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2
measure: Need for dialysis
time frame: 30 days
description: Number of patients with any dialysis given within 30 days of surgery
arm group label: Digifab
arm group type: Active Comparator
description: Digifab intravenous
arm group label: Placebo
arm group type: Placebo Comparator
description: saline intravenous
intervention type: Drug
intervention name: Digoxin Antibodies Fab Fragments
description: Digoxin antibodies
arm group label: Digifab
intervention type: Other
intervention name: Placebo
description: Saline
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen S Gottlieb
role: Principal Investigator
affiliation: University of Maryland
last name: Stephen Gottlieb, MD
phone: 4103288788
email: sgottlie@medicine.umaryland.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Stephen Gottlieb
investigator title: Professor of Medicine
mesh term: Acute Kidney Injury
mesh term: Digoxin
mesh term: Antibodies
mesh term: Immunoglobulin Fab Fragments
sharing ipd: No