Study Stopped
Discontinuation of all bardoxolone chronic kidney disease programs
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
2 other identifiers
interventional
270
6 countries
87
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2019
Typical duration for phase_3
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2018
CompletedFirst Posted
Study publicly available on registry
November 21, 2018
CompletedStudy Start
First participant enrolled
March 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2023
CompletedResults Posted
Study results publicly available
March 19, 2024
CompletedJune 3, 2025
May 1, 2025
4.5 years
November 19, 2018
February 20, 2024
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
Bardoxolone methyl
EXPERIMENTALAdult 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- 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);
- BNP \< 200 pg/mL at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable;
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (87)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Apogee Clinical Research
Huntsville, Alabama, 35805, United States
Arizona Kidney Disease and Hypertension Research Services, PLLC
Glendale, Arizona, 85306, United States
Centricity Research Phoenix Multispecialty
Mesa, Arizona, 85206, United States
California Institute Renal Research
La Mesa, California, 91942, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
Apex Research of Riverside
Riverside, California, 92505, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
University of California San Francisco - Children's Renal Center
San Francisco, California, 94143, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Western Nephrology
Arvada, Colorado, 80002, United States
University of Colorado Anschutz Medical Center
Aurora, Colorado, 80045, United States
Colorado Kidney Care, PC
Denver, Colorado, 80230, United States
South Florida Research Institute
Lauderdale Lakes, Florida, 33313, United States
Innovation Medical Research, Inc.
Palmetto Bay, Florida, 33157, United States
USF Health South Tampa Center
Tampa, Florida, 33606, United States
Florida Premier Research Institute, LLC
Winter Park, Florida, 32789, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Boise Kidney & Hypertension, PLLC
Caldwell, Idaho, 83605, United States
Boise Kidney & Hypertension, PLLC
Meridian, Idaho, 83642, United States
Northwestern University
Chicago, Illinois, 60611, United States
Nephrology Research NorthShore University Health System
Evanston, Illinois, 60201, United States
University of Kansas Medical Center
Kansas City, Kansas, 66224, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101, United States
The Johns Hopkins University
Baltimore, Maryland, 21287, United States
Tufts Medical Center - Division of Nephrology
Boston, Massachusetts, 02110, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Nephrology Center, PC
Kalamazoo, Michigan, 49007, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64108, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
KSOSN
Las Vegas, Nevada, 89128, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia University Medical Center
New York, New York, 10032, United States
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, 28801, United States
North Carolina Nephrology
Cary, North Carolina, 27511, United States
Metrolina Nephrology Associates
Charlotte, North Carolina, 28208, United States
Duke University Medical Center
Durham, North Carolina, 27701, United States
Metrolina Nephrology Associates
Gastonia, North Carolina, 28054, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Remington-Davis Clinical Research
Columbus, Ohio, 43215, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Columbia Nephrology Associates, PA
Columbia, South Carolina, 29203, United States
South Carolina Nephrology & Hypertension Center, Inc
Orangeburg, South Carolina, 29118, United States
Arlington Nephrology
Arlington, Texas, 76015, United States
Research Management, Inc.
Austin, Texas, 78751, United States
Renal Disease Research Institute
Dallas, Texas, 75204, United States
DaVita Med Center
Houston, Texas, 77004, United States
Southwest Houston Research
Houston, Texas, 77099, United States
Clinical Advancement Center
San Antonio, Texas, 78215, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Nephrology Associates of Northern Virginia, Inc.
Fairfax, Virginia, 22033, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Milwaukee Nephrologists, SC
Wauwatosa, Wisconsin, 53226, United States
John Hunter Hospital
New Lambton, New South Wales, 2305, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Melbourne Renal Research Group
Reservoir, Victoria, 3073, Australia
The Royal Melbourne Hospital
Parkville, 3050, Australia
Chu Grenoble Alpes
Grenoble, 38043, France
Hopital Necker, Universite Paris Descartes
Paris, 75015, France
Japanese Red Cross Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Toranomon Hospital Kajigaya
Kawasaki, Kanagawa, 213-8587, Japan
St Marianna University Hospital
Kawasaki, Kanagawa, 216-8511, Japan
JCHO Sendai Hospital
Sendai, Miyagi, 981-3281, Japan
Kitano Hospital
Osaka, Osaka, 530-8480, Japan
Osaka University Hospital
Suita, Osaka, 565-8971, Japan
Saga University Hospital
Saga, Saga-ken, 849-8501, Japan
Saitama Children's Medical Center
Saitama-shi, Saitama, 330-8777, Japan
Juntendo University Hospital
Bunkyō-Ku, Tokyo, 113-8431, Japan
Jutendo University Hospital
Bunkyō-Ku, Tokyo, 113-8431, Japan
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, 183-8561, Japan
Toranomon Hospital
Minato-Ku, Tokyo, 105-8470, Japan
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, 162-8666, Japan
Niigata University Medical and Dental Hospital
Niigata, 951-8520, Japan
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
Osaka, 834-0021, Japan
Puerto Rico Clinical and Translational Research Consortium (PRCTRC)
Rio Piedras, 00935, Puerto Rico
Fundacio Puigvert
Barcelona, Catalonia, 08025, Spain
Hospital Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination of trial due to discontinuation of all bardoxolone chronic kidney disease programs.
Results Point of Contact
- Title
- US Biogen Clinical Trial Center
- Organization
- Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2018
First Posted
November 21, 2018
Study Start
March 8, 2019
Primary Completion
August 23, 2023
Study Completion
August 23, 2023
Last Updated
June 3, 2025
Results First Posted
March 19, 2024
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/