An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) (EAGLE)

An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Kidney Diseases; Autosomal Dominant Polycystic Kidney; Alport Syndrome
• Intervention / Treatment: Drug: Bardoxolone methyl

Detailed Description

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Parkville, Australia, 3050
    • The Royal Melbourne Hospital
  • New South Wales
    • New Lambton, New South Wales, Australia, 2305
      • John Hunter Hospital
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
  • Victoria
    • Reservoir, Victoria, Australia, 3073
      • Melbourne Renal Research Group
• France
  • Grenoble, France, 38043
    • Chu Grenoble Alpes
  • Paris, France, 75015
    • Hopital Necker, Universite Paris Descartes
• Japan
  • Niigata, Japan, 951-8520
    • Niigata University Medical and Dental Hospital
  • Osaka, Japan, 834-0021
    • Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
  • Aichi
    • Nagoya-shi, Aichi, Japan, 466-8650
      • Japanese Red Cross Nagoya Daini Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Hyogo
    • Kobe City, Hyogo, Japan, 650-0017
      • Kobe University Hospital
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 213-8587
      • Toranomon Hospital Kajigaya
    • Kawasaki, Kanagawa, Japan, 216-8511
      • St Marianna University Hospital
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 981-3281
      • JCHO Sendai Hospital
  • Osaka
    • Osaka-shi, Osaka, Japan, 530-8480
      • Kitano Hospital
    • Suita, Osaka, Japan, 565-8971
      • Osaka University Hospital
  • Saga
    • Saga-shi, Saga, Japan, 849-8501
      • Saga University Hospital
  • Saitama
    • Saitama-shi, Saitama, Japan, 330-8777
      • Saitama Children's Medical Center
  • Tokyo
    • Bunkyō-Ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Bunkyō-Ku, Tokyo, Japan, 113-8431
      • Jutendo University Hospital
    • Fuchū, Tokyo, Japan, 183-8561
      • Tokyo Metropolitan Children's Medical Center
    • Minato-Ku, Tokyo, Japan, 105-8470
      • Toranomon Hospital
    • Shinjuku-Ku, Tokyo, Japan, 162-8666
      • Tokyo Women's Medical University Hospital
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Puerto Rico Clinical and Translational Research Consortium (PRCTRC)
• Spain
  • Cataluna
    • Barcelona, Cataluna, Spain, 08025
      • Fundacio Puigvert
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Virgen de la Arrixaca
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Huntsville, Alabama, United States, 35805
      • Apogee Clinical Research
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arizona Kidney Disease and Hypertension Research Services, PLLC
    • Mesa, Arizona, United States, 85206
      • Centricity Research Phoenix Multispecialty
  • California
    • La Mesa, California, United States, 91942
      • California Institute Renal Research
    • Los Angeles, California, United States, 90095
      • David Geffen School of Medicine at UCLA
    • Los Angeles, California, United States, 90022
      • Academic Medical Research Institute
    • Riverside, California, United States, 92505
      • Apex Research of Riverside
    • San Diego, California, United States, 92123
      • Rady Children's Hospital - San Diego
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • San Francisco, California, United States, 94143
      • University of California San Francisco - Children's Renal Center
  • Colorado
    • Arvada, Colorado, United States, 80002
      • Western Nephrology
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Center
    • Denver, Colorado, United States, 80230
      • Colorado Kidney Care, PC
  • Florida
    • Lauderdale Lakes, Florida, United States, 33313
      • South Florida Research Institute
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Research, Inc.
    • Tampa, Florida, United States, 33606
      • USF Health South Tampa Center
    • Winter Park, Florida, United States, 32789
      • Florida Premier Research Institute, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
  • Idaho
    • Caldwell, Idaho, United States, 83605
      • Boise Kidney & Hypertension, PLLC
    • Meridian, Idaho, United States, 83642
      • Boise Kidney & Hypertension, PLLC
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Evanston, Illinois, United States, 60201
      • Nephrology Research NorthShore University Health System
  • Kansas
    • Kansas City, Kansas, United States, 66224
      • University of Kansas Medical Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Renal Associates of Baton Rouge
    • Shreveport, Louisiana, United States, 71101
      • Northwest Louisiana Nephrology
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02110
      • Tufts Medical Center - Division of Nephrology
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Kalamazoo, Michigan, United States, 49007
      • Nephrology Center, PC
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Clinical Research Consultants, LLC
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital and Clinics
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • KSOSN
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mountain Kidney & Hypertension Associates
    • Cary, North Carolina, United States, 27511
      • North Carolina Nephrology
    • Charlotte, North Carolina, United States, 28208
      • Metrolina Nephrology Associates
    • Durham, North Carolina, United States, 27701
      • Duke University Medical Center
    • Gastonia, North Carolina, United States, 28054
      • Metrolina Nephrology Associates
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43215
      • Remington-Davis Clinical Research
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Northeast Clinical Research Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Columbia Nephrology Associates, PA
    • Orangeburg, South Carolina, United States, 29118
      • South Carolina Nephrology & Hypertension Center, Inc
  • Texas
    • Arlington, Texas, United States, 76015
      • Arlington Nephrology
    • Austin, Texas, United States, 78751
      • Research Management, Inc.
    • Dallas, Texas, United States, 75204
      • Renal Disease Research Institute
    • Houston, Texas, United States, 77099
      • Southwest Houston Research
    • Houston, Texas, United States, 77004
      • DaVita Med Center
    • San Antonio, Texas, United States, 78215
      • Clinical Advancement Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center
  • Virginia
    • Fairfax, Virginia, United States, 22033
      • Nephrology Associates of Northern Virginia, Inc.
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Milwaukee Nephrologists, Sc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who are participating (or who have participated) in qualifying studies and who have not been required to discontinue study treatment for protocol or safety reasons and who have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl and who, according to the assessment of the investigator, have a potential positive benefit-risk assessment for participating in the trial.

• Meets the following eligibility criteria based on assessments from the prior qualifying study (last on-treatment visit) or from a screening visit, if applicable:

  1. Not expected to reach end stage kidney disease (ESKD) or nephrotic syndrome within 12 weeks of study enrollment, in the investigator's judgement; subjects with eGFR <20 ml/min/1.73m2 should be discussed with the medical monitor before enrollment (e.g., such subjects with an average rate of eGFR decline > 1.0 ml/min/1.73m2 per month in the 3 months prior to eligibility assessment may not be eligible);
  2. BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable;
  3. No occurrence of a cardiovascular serious adverse event in the prior qualifying study or in the interval between the end of the qualifying study and the screening visit, if applicable.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Evidence of a personally signed and dated informed consent document (and assent form if necessary) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures.

Exclusion Criteria:

• Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication;
• Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl;
• Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while screening, taking study drug and 30 days after the last study drug dose;
• Women who are pregnant or breastfeeding;
• Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason;
• Known hypersensitivity to any component of the study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bardoxolone methyl; Adult participants received bardoxolone methyl capsules, once daily (QD) at a starting dose of 5 milligrams (mg), followed by dose- escalation to 10 mg at Week 2 (Day 14 ± 3), and to 20 mg at Week 4 (Day 28 ± 3). Based on the eligibility UACR >300 milligrams per gram (mg/g), the dose was increased to 30 mg starting from Week 6 (Day 42 ± 3) until the end of the study. Participants under 18 years of age received bardoxolone methyl capsules at a starting dose of 5 mg every other day during the first week and QD during the second week of the study, followed by dose-escalation to 10 mg at Week 2 and to 20 mg at Week 4. Based on the eligibility UACR >300 mg/g, the dose was increased to 30 mg starting from Week 6 until the end of the study.

Drug: Bardoxolone methyl; Bardoxolone methyl capsules; Other Names: RTA 402

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. AEs and SAEs that occurred within 30 days after the last dose were considered treatment-emergent. The study follow-up assessment was collected within 14 to 35 days after the last dose.	From the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years)

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2019
• Primary Completion (Actual): August 23, 2023
• Study Completion (Actual): August 23, 2023

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: ADPKD; RTA 402; Bardoxolone methyl; Autosomal Dominant Polycystic Kidney; Alport Syndrome; CDDO-ME
• Additional Relevant MeSH Terms: Ciliopathies; Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Genetic Diseases, Inborn; Connective Tissue Diseases; Renal Insufficiency; Congenital Abnormalities; Abnormalities, Multiple; Urogenital Abnormalities; Nephritis; Collagen Diseases; Kidney Diseases, Cystic; Kidney Diseases; Renal Insufficiency, Chronic; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Nephritis, Hereditary
• Other Study ID Numbers: 402-C-1803; 2018-003253-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No