<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/NCT04496596</url>
  </required_header>
  <id_info>
    <org_study_id>RLS003-02-001</org_study_id>
    <nct_id>NCT04496596</nct_id>
  </id_info>
  <brief_title>Study of Suramin in Subjects With Furosemide-Resistant AKI</brief_title>
  <official_title>A Prospective, Double-Blind, Placebo-controlled Study of Suramin in Subjects With Furosemide-Resistant Acute Kidney Injury (AKI): Efficacy in Preventing Dialysis Dependent AKI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rediscovery Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rediscovery Life Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, double-blind, randomized, placebo-controlled study to assess the&#xD;
      effects of suramin as a potential treatment option to prevent subjects with AKI from&#xD;
      progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III or dialysis&#xD;
      dependent AKI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 13, 2020</start_date>
  <completion_date type="Anticipated">December 22, 2023</completion_date>
  <primary_completion_date type="Actual">April 17, 2023</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI</measure>
    <time_frame>7 days</time_frame>
    <description>The difference between the effect of a 3.0 mg/kg infusion of suramin versus placebo will be based on meeting 2 or more of the composite event endpoints of: peak serum creatinine (Cr) of 6 mg/dL or above from investigational product (IP) infusion through Day or progression to KDIGO Stage III within 72 hours (hr) from IP infusion or death or dialysis from IP infusion through Day 7.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Suramin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Suramin</intervention_name>
    <description>Suramin is administered via IV infusion as a single dose of 3 mg/kg</description>
    <arm_group_label>Suramin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age at the time of signing the informed consent&#xD;
&#xD;
          -  KDIGO Stage I AKI and a serum Cr increase ≥ 0.3 mg/dL within 48 hr or 1.5 to 1.9-times&#xD;
             baseline (pre-FST) Cr levels within 48 hr (± 6 hr) prior to randomization OR KDIGO&#xD;
             Stage II AKI and serum Cr increase 2.0 to 2.9-times baseline (pre-FST) Cr levels&#xD;
             within 48 hr (± 6 hr) prior to randomization&#xD;
&#xD;
          -  Fails to achieve a 200 mL increase in urine output within 2 hr following a 1.0 mg/kg&#xD;
             bolus of furosemide (i.e., positive FST)&#xD;
&#xD;
          -  If female of childbearing potential, must have a negative pregnancy test at Screening&#xD;
             Is capable of providing informed consent as described in in this protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving hemodialysis or peritoneal dialysis&#xD;
&#xD;
          -  Prior renal transplant (other organ transplants are not excluded)&#xD;
&#xD;
          -  Known baseline (pre-FST) estimated glomerular filtration rate (eGFR) ≤ 20 mL/min&#xD;
&#xD;
          -  Evidence of hydronephrosis or obstructive uropathy confirmed by renal ultrasound (for&#xD;
             subjects without a documented ultrasound, the&#xD;
&#xD;
          -  Investigator will determine if a renal ultrasound is indicated, consistent with the&#xD;
             standard of care (SOC)&#xD;
&#xD;
          -  Hepatic encephalopathy, Child class C cirrhosis, and/or clinical suspicion of&#xD;
             hepatorenal syndrome&#xD;
&#xD;
          -  International normalized ratio (INR) ≤ 3.0, unless on stable long-term warfarin&#xD;
             therapy within 2 weeks prior to randomization&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection&#xD;
&#xD;
          -  Known coronavirus (COVID-19) infection&#xD;
&#xD;
          -  White blood cell count (WBC) &lt; 2,000/μL and/or platelet count &lt; 30,000/μL at the time&#xD;
             of Screening&#xD;
&#xD;
          -  A sequential organ failure assessment (SOFA) score &gt; 10 during Screening&#xD;
&#xD;
          -  Subjects requiring 3 or more vasopressor agents of any combination to maintain a mean&#xD;
             arterial pressure &gt; 65 mm Hg&#xD;
&#xD;
          -  Unwilling to participate in follow-up phone surveys up to 180 days post-treatment&#xD;
&#xD;
          -  Are enrolled in another interventional research study or have participated in another&#xD;
             interventional study within 14 days of Screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Arkansas Medical Sciences (UAMS)</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Institute of Renal Research</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ronald Reagan UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>900953</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Johns Creek Hospital</name>
      <address>
        <city>Johns Creek</city>
        <state>Georgia</state>
        <zip>30097</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri - Dept. of Surgery</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Health Science Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York-Presbyterian Medical Center of Queens</name>
      <address>
        <city>Flushing</city>
        <state>New York</state>
        <zip>11355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157-1009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Renal Research Institute</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott and White Research Institute - Dallas Clinical Trials Office</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</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>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suramin</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/NCT04496596
org study id: RLS003-02-001
nct id: NCT04496596
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a prospective, double-blind, randomized, placebo-controlled study to assess the
      effects of suramin as a potential treatment option to prevent subjects with AKI from
      progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III or dialysis
      dependent AKI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI
time frame: 7 days
description: The difference between the effect of a 3.0 mg/kg infusion of suramin versus placebo will be based on meeting 2 or more of the composite event endpoints of: peak serum creatinine (Cr) of 6 mg/dL or above from investigational product (IP) infusion through Day or progression to KDIGO Stage III within 72 hours (hr) from IP infusion or death or dialysis from IP infusion through Day 7.
arm group label: Suramin
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Suramin
description: Suramin is administered via IV infusion as a single dose of 3 mg/kg
arm group label: Suramin
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Suramin
sharing ipd: No