<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/NCT03749447</url>
  </required_header>
  <id_info>
    <org_study_id>402-C-1803</org_study_id>
    <nct_id>NCT03749447</nct_id>
  </id_info>
  <brief_title>An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)</brief_title>
  <acronym>EAGLE</acronym>
  <official_title>An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Reata Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Reata Pharmaceuticals, Inc.</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>
      This extended access study will assess the long-term safety and tolerability of bardoxolone&#xD;
      methyl in qualified patients with chronic kidney disease (CKD) who previously participated in&#xD;
      one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the&#xD;
      study until bardoxolone methyl is available through commercial channels or until patient&#xD;
      withdrawal, whichever is sooner.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Discontinuation of all bardoxolone chronic kidney disease programs&#xD;
  </why_stopped>
  <start_date type="Actual">March 8, 2019</start_date>
  <completion_date type="Actual">May 10, 2023</completion_date>
  <primary_completion_date type="Actual">May 10, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Long-term safety: by incidence of adverse events and serious adverse events</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Long-term safety as measured by incidence of adverse events and serious adverse events during the study duration</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">271</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <condition>Alport Syndrome</condition>
  <condition>Autosomal Dominant Polycystic Kidney</condition>
  <arm_group>
    <arm_group_label>Bardoxolone methyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The maximum dosage is determined by proteinuria status from the last on-treatment visit in the prior qualifying study or a screening visit, if necessary. Initial daily dose of bardoxolone methyl will dose-escalate at Week 2, Week 4, and Week 6.&#xD;
Patients under the age of 18 will start dosing with bardoxolone methyl capsules every other day during Week 1 and daily at Week 2.&#xD;
Patients will receive doses of bardoxolone methyl capsules in an escalating scheme from 5 mg up to no more than 30 mg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bardoxolone methyl</intervention_name>
    <description>Bardoxolone methyl capsules</description>
    <arm_group_label>Bardoxolone methyl</arm_group_label>
    <other_name>RTA 402</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are participating (or who have participated) in qualifying studies and&#xD;
             who have not been required to discontinue study treatment for protocol or safety&#xD;
             reasons and who have completed required End-of-Treatment and/or Follow-up visits in a&#xD;
             prior clinical study with bardoxolone methyl and who, according to the assessment of&#xD;
             the investigator, have a potential positive benefit-risk assessment for participating&#xD;
             in the trial.&#xD;
&#xD;
          -  Meets the following eligibility criteria based on assessments from the prior&#xD;
             qualifying study (last on-treatment visit) or from a screening visit, if applicable:&#xD;
&#xD;
               1. Not expected to reach end stage kidney disease (ESKD) or nephrotic syndrome&#xD;
                  within 12 weeks of study enrollment, in the investigator's judgement; subjects&#xD;
                  with eGFR &lt;20 ml/min/1.73m2 should be discussed with the medical monitor before&#xD;
                  enrollment (e.g., such subjects with an average rate of eGFR decline &gt; 1.0&#xD;
                  ml/min/1.73m2 per month in the 3 months prior to eligibility assessment may not&#xD;
                  be eligible);&#xD;
&#xD;
               2. BNP &lt; 200 pg/mL at the last on-treatment visit in the prior qualifying study or&#xD;
                  at a new screening visit, if applicable;&#xD;
&#xD;
               3. No occurrence of a cardiovascular serious adverse event in the prior qualifying&#xD;
                  study or in the interval between the end of the qualifying study and the&#xD;
                  screening visit, if applicable.&#xD;
&#xD;
          -  Willing and able to comply with scheduled visits, treatment plan, laboratory tests,&#xD;
             and other study procedures.&#xD;
&#xD;
          -  Evidence of a personally signed and dated informed consent document (and assent form&#xD;
             if necessary) indicating that the patient (or a legally acceptable representative) has&#xD;
             been informed of all pertinent aspects of the study prior to initiation of any&#xD;
             protocol-mandated procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in other investigational clinical studies involving interventional&#xD;
             products being tested or used in a way different from the approved form or when used&#xD;
             for an unapproved indication;&#xD;
&#xD;
          -  Patients who have an ongoing SAE from a clinical study that is assessed by the&#xD;
             investigator as related to bardoxolone methyl;&#xD;
&#xD;
          -  Unwilling to practice acceptable methods of birth control (both males who have&#xD;
             partners of childbearing potential and females of childbearing potential) while&#xD;
             screening, taking study drug and 30 days after the last study drug dose;&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding;&#xD;
&#xD;
          -  Patient is, in the opinion of the investigator, unable to comply with the requirements&#xD;
             of the study protocol or is unsuitable for the study for any reason;&#xD;
&#xD;
          -  Known hypersensitivity to any component of the study drug.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apogee Clinical Research</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Kidney Disease and Hypertension Research Services, PLLC</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centricity Research Phoenix Multispecialty</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Institute Renal Research</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Medical Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>David Geffen School of Medicine at UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apex Research of Riverside</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital - San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco - Children's Renal Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Nephrology</name>
      <address>
        <city>Arvada</city>
        <state>Colorado</state>
        <zip>80002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Kidney Care, PC</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Research Institute</name>
      <address>
        <city>Lauderdale Lakes</city>
        <state>Florida</state>
        <zip>33313</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovation Medical Research, Inc.</name>
      <address>
        <city>Palmetto Bay</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USF Health South Tampa Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Premier Research Institute, LLC</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</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>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boise Kidney &amp; Hypertension, PLLC</name>
      <address>
        <city>Caldwell</city>
        <state>Idaho</state>
        <zip>83605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boise Kidney &amp; Hypertension, PLLC</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nephrology Research NorthShore University Health System</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal Associates of Baton Rouge</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Louisiana Nephrology</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center - Division of Nephrology</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nephrology Center, PC</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital and Clinics</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Consultants, LLC</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KSOSN</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain Kidney &amp; Hypertension Associates</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Carolina Nephrology</name>
      <address>
        <city>Cary</city>
        <state>North Carolina</state>
        <zip>27511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metrolina Nephrology Associates</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metrolina Nephrology Associates</name>
      <address>
        <city>Gastonia</city>
        <state>North Carolina</state>
        <zip>28054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Remington-Davis Clinical Research</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Clinical Research Center</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Children's Hospital of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Nephrology Associates, PA</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Carolina Nephrology &amp; Hypertension Center, Inc</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arlington Nephrology</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Management, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal Disease Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Med Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Houston Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Advancement Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Vermont Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nephrology Associates of Northern Virginia, Inc.</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Milwaukee Nephrologists, SC</name>
      <address>
        <city>Wauwatosa</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Hunter Hospital</name>
      <address>
        <city>New Lambton</city>
        <state>New South Wales</state>
        <zip>2305</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melbourne Renal Research Group</name>
      <address>
        <city>Reservoir</city>
        <state>Victoria</state>
        <zip>3073</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Grenoble Alpes</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Necker, Universite Paris Descartes</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Nagoya Daini Hospital</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>466-8650</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital</name>
      <address>
        <city>Kobe City</city>
        <state>Hyogo</state>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toranomon Hospital Kajigaya</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>213-8587</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Marianna University Hospital</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>216-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JCHO Sendai Hospital</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>981-3281</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kitano Hospital</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>530-8480</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>565-8971</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saga University Hospital</name>
      <address>
        <city>Saga-shi</city>
        <state>Saga</state>
        <zip>849-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Children's Medical Center</name>
      <address>
        <city>Saitama-shi</city>
        <state>Saitama</state>
        <zip>330-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital</name>
      <address>
        <city>Bunkyō-Ku</city>
        <state>Tokyo</state>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jutendo University Hospital</name>
      <address>
        <city>Bunkyō-Ku</city>
        <state>Tokyo</state>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Metropolitan Children's Medical Center</name>
      <address>
        <city>Fuchū</city>
        <state>Tokyo</state>
        <zip>183-8561</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toranomon Hospital</name>
      <address>
        <city>Minato-Ku</city>
        <state>Tokyo</state>
        <zip>105-8470</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Hospital</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <zip>162-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata University Medical and Dental Hospital</name>
      <address>
        <city>Niigata</city>
        <zip>951-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>834-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Puerto Rico Clinical and Translational Research Consortium (PRCTRC)</name>
      <address>
        <city>Rio Piedras</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacio Puigvert</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluna</state>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Arrixaca</name>
      <address>
        <city>El Palmar</city>
        <state>Murcia</state>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>France</country>
    <country>Japan</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>June 1, 2023</last_update_submitted>
  <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bardoxolone methyl</keyword>
  <keyword>CDDO-ME</keyword>
  <keyword>RTA 402</keyword>
  <keyword>Alport Syndrome</keyword>
  <keyword>Autosomal Dominant Polycystic Kidney</keyword>
  <keyword>ADPKD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Polycystic Kidney Diseases</mesh_term>
    <mesh_term>Polycystic Kidney, Autosomal Dominant</mesh_term>
    <mesh_term>Nephritis, Hereditary</mesh_term>
  </condition_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/NCT03749447
org study id: 402-C-1803
nct id: NCT03749447
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This extended access study will assess the long-term safety and tolerability of bardoxolone
      methyl in qualified patients with chronic kidney disease (CKD) who previously participated in
      one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the
      study until bardoxolone methyl is available through commercial channels or until patient
      withdrawal, whichever is sooner.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Long-term safety: by incidence of adverse events and serious adverse events
time frame: Up to 5 years
description: Long-term safety as measured by incidence of adverse events and serious adverse events during the study duration
arm group label: Bardoxolone methyl
arm group type: Experimental
description: The maximum dosage is determined by proteinuria status from the last on-treatment visit in the prior qualifying study or a screening visit, if necessary. Initial daily dose of bardoxolone methyl will dose-escalate at Week 2, Week 4, and Week 6.
Patients under the age of 18 will start dosing with bardoxolone methyl capsules every other day during Week 1 and daily at Week 2.
Patients will receive doses of bardoxolone methyl capsules in an escalating scheme from 5 mg up to no more than 30 mg.
intervention type: Drug
intervention name: Bardoxolone methyl
description: Bardoxolone methyl capsules
arm group label: Bardoxolone methyl
other name: RTA 402
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
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country: Australia
country: France
country: Japan
country: Puerto Rico
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Polycystic Kidney Diseases
mesh term: Polycystic Kidney, Autosomal Dominant
mesh term: Nephritis, Hereditary
sharing ipd: No