Chronic Kidney DiseasesPhase 3EAGLENCT03749447
An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
A Phase 3 study testing Bardoxolone methyl in people with Chronic Kidney Diseases and Alport Syndrome, run by Biogen at 87 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Alport Syndrome, Autosomal Dominant Polycystic Kidney
- What is being tested?
- Bardoxolone methyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 87 sitesin 6 countries
- Study dates
- 8 Mar 2019to 23 Aug 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
87 sites in 6 countries.
87 sites in 6 countries
United States61 sites
University of Michigan
Ann Arbor, Michigan, 48109
Arlington Nephrology
Arlington, Texas, 76015
Western Nephrology
Arvada, Colorado, 80002
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, 28801
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Colorado Anschutz Medical Center
Aurora, Colorado, 80045
Research Management, Inc.
Austin, Texas, 78751
The Johns Hopkins University
Baltimore, Maryland, 21287
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tufts Medical Center - Division of Nephrology
Boston, Massachusetts, 02110
Tufts Medical Center
Boston, Massachusetts, 02111
University of Vermont Medical Center
Burlington, Vermont, 05401
Boise Kidney & Hypertension, PLLC
Caldwell, Idaho, 83605
North Carolina Nephrology
Cary, North Carolina, 27511
Metrolina Nephrology Associates
Charlotte, North Carolina, 28208
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Columbia Nephrology Associates, PA
Columbia, South Carolina, 29203
Remington-Davis Clinical Research
Columbus, Ohio, 43215
Renal Disease Research Institute
Dallas, Texas, 75204
Colorado Kidney Care, PC
Denver, Colorado, 80230
Duke University Medical Center
Durham, North Carolina, 27701
Nephrology Research NorthShore University Health System
Evanston, Illinois, 60201
Nephrology Associates of Northern Virginia, Inc.
Fairfax, Virginia, 22033
Metrolina Nephrology Associates
Gastonia, North Carolina, 28054
Arizona Kidney Disease and Hypertension Research Services, PLLC
Glendale, Arizona, 85306
Hackensack University Medical Center
Hackensack, New Jersey, 07601
DaVita Med Center
Houston, Texas, 77004
Southwest Houston Research
Houston, Texas, 77099
Apogee Clinical Research
Huntsville, Alabama, 35805
Nephrology Center, PC
Kalamazoo, Michigan, 49007
University of Kansas Medical Center
Kansas City, Kansas, 66224
Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64108
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111
California Institute Renal Research
La Mesa, California, 91942
KSOSN
Las Vegas, Nevada, 89128
South Florida Research Institute
Lauderdale Lakes, Florida, 33313
Academic Medical Research Institute
Los Angeles, California, 90022
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Boise Kidney & Hypertension, PLLC
Meridian, Idaho, 83642
Centricity Research Phoenix Multispecialty
Mesa, Arizona, 85206
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Columbia University Medical Center
New York, New York, 10032
South Carolina Nephrology & Hypertension Center, Inc
Orangeburg, South Carolina, 29118
Innovation Medical Research, Inc.
Palmetto Bay, Florida, 33157
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Oregon Health and Science University
Portland, Oregon, 97239
Apex Research of Riverside
Riverside, California, 92505
Mayo Clinic
Rochester, Minnesota, 55905
Clinical Advancement Center
San Antonio, Texas, 78215
Rady Children's Hospital - San Diego
San Diego, California, 92123
University of California San Francisco - Children's Renal Center
San Francisco, California, 94143
University of California, San Francisco
San Francisco, California, 94143
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101
Washington University School of Medicine
St Louis, Missouri, 63110
USF Health South Tampa Center
Tampa, Florida, 33606
Milwaukee Nephrologists, SC
Wauwatosa, Wisconsin, 53226
Florida Premier Research Institute, LLC
Winter Park, Florida, 32789
Japan17 sites
Juntendo University Hospital
Bunkyō-Ku, Tokyo, 113-8431
Jutendo University Hospital
Bunkyō-Ku, Tokyo, 113-8431
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, 183-8561
Toranomon Hospital Kajigaya
Kawasaki, Kanagawa, 213-8587
St Marianna University Hospital
Kawasaki, Kanagawa, 216-8511
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Toranomon Hospital
Minato-Ku, Tokyo, 105-8470
Japanese Red Cross Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650
Niigata University Medical and Dental Hospital
Niigata, 951-8520
Kitano Hospital
Osaka, Osaka, 530-8480
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
Osaka, 834-0021
Saga University Hospital
Saga, Saga-ken, 849-8501
Saitama Children's Medical Center
Saitama-shi, Saitama, 330-8777
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
JCHO Sendai Hospital
Sendai, Miyagi, 981-3281
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, 162-8666
Osaka University Hospital
Suita, Osaka, 565-8971
Australia4 sites
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
John Hunter Hospital
New Lambton, New South Wales, 2305
The Royal Melbourne Hospital
Parkville, 3050
Melbourne Renal Research Group
Reservoir, Victoria, 3073
France2 sites
Chu Grenoble Alpes
Grenoble, 38043
Hopital Necker, Universite Paris Descartes
Paris, 75015
Spain2 sites
Fundacio Puigvert
Barcelona, Catalonia, 08025
Hospital Virgen de la Arrixaca
El Palmar, Murcia, 30120
Puerto Rico1 site
Puerto Rico Clinical and Translational Research Consortium (PRCTRC)
Rio Piedras, 00935
About this study
Official title: 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.
- Being tested
- Bardoxolone methyl
- Keywords
- Bardoxolone methyl, CDDO-ME, RTA 402, Alport Syndrome, Autosomal Dominant Polycystic Kidney, ADPKD
- Medical subject headings
- Renal Insufficiency, Chronic, Nephritis, Hereditary, Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bardoxolone methylDrug
Also called RTA 402
Bardoxolone methyl capsules
| Study group | Role | What they receive |
|---|---|---|
| Bardoxolone methyl | Experimental | 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. Receives: Drug: Bardoxolone methyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start8 Mar 2019
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Why it stopped: Discontinuation of all bardoxolone chronic kidney disease programs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749447
- Sponsor's protocol ID
- 402-C-1803
- Other IDs
- 2018-003253-24, 2018
- Acronym
- EAGLE
- Status last verified
- May 2025
- First submitted
- 19 Nov 2018
- Last updated
- 3 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03749447
- Acronym / sponsor ID
- EAGLE / 402-C-1803
- Keywords
- Bardoxolone methyl, CDDO-ME, RTA 402, Alport Syndrome, Autosomal Dominant Polycystic Kidney, ADPKD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinuation of all bardoxolone chronic kidney disease programs
- Enrolment
- 270 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bardoxolone methyl | Experimental | Drug: Bardoxolone methylAdult 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bardoxolone methylAlso: RTA 402Bardoxolone methyl capsules | Drug | Bardoxolone methyl |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
87 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bardoxolone methyl in people with Chronic Kidney Diseases and Alport Syndrome, run by Biogen at 87 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States, Japan, Australia, France, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.