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

NCT ID: NCT03749447

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-08
• Study Completion Date: 2023-08-23

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.

Conditions

Chronic Kidney Diseases; Alport Syndrome; Autosomal Dominant Polycystic Kidney

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bardoxolone methyl

Intervention Type: DRUG

Bardoxolone methyl capsules

Interventions

Bardoxolone methyl

Bardoxolone methyl capsules

Intervention Type: DRUG

Other Intervention Names

RTA 402

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Apogee Clinical Research

Huntsville, Alabama, United States

Arizona Kidney Disease and Hypertension Research Services, PLLC

Glendale, Arizona, United States

Centricity Research Phoenix Multispecialty

Mesa, Arizona, United States

California Institute Renal Research

La Mesa, California, United States

Academic Medical Research Institute

Los Angeles, California, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Apex Research of Riverside

Riverside, California, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

University of California San Francisco - Children's Renal Center

San Francisco, California, United States

University of California, San Francisco

San Francisco, California, United States

Western Nephrology

Arvada, Colorado, United States

University of Colorado Anschutz Medical Center

Aurora, Colorado, United States

Colorado Kidney Care, PC

Denver, Colorado, United States

South Florida Research Institute

Lauderdale Lakes, Florida, United States

Innovation Medical Research, Inc.

Palmetto Bay, Florida, United States

USF Health South Tampa Center

Tampa, Florida, United States

Florida Premier Research Institute, LLC

Winter Park, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Boise Kidney & Hypertension, PLLC

Caldwell, Idaho, United States

Boise Kidney & Hypertension, PLLC

Meridian, Idaho, United States

Northwestern University

Chicago, Illinois, United States

Nephrology Research NorthShore University Health System

Evanston, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Renal Associates of Baton Rouge

Baton Rouge, Louisiana, United States

Northwest Louisiana Nephrology

Shreveport, Louisiana, United States

The Johns Hopkins University

Baltimore, Maryland, United States

Tufts Medical Center - Division of Nephrology

Boston, Massachusetts, United States

Tufts Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Nephrology Center, PC

Kalamazoo, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Children's Mercy Hospital and Clinics

Kansas City, Missouri, United States

Clinical Research Consultants, LLC

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

KSOSN

Las Vegas, Nevada, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Columbia University Medical Center

New York, New York, United States

Mountain Kidney & Hypertension Associates

Asheville, North Carolina, United States

North Carolina Nephrology

Cary, North Carolina, United States

Metrolina Nephrology Associates

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Metrolina Nephrology Associates

Gastonia, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Remington-Davis Clinical Research

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Northeast Clinical Research Center

Bethlehem, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Columbia Nephrology Associates, PA

Columbia, South Carolina, United States

South Carolina Nephrology & Hypertension Center, Inc

Orangeburg, South Carolina, United States

Arlington Nephrology

Arlington, Texas, United States

Research Management, Inc.

Austin, Texas, United States

Renal Disease Research Institute

Dallas, Texas, United States

DaVita Med Center

Houston, Texas, United States

Southwest Houston Research

Houston, Texas, United States

Clinical Advancement Center

San Antonio, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Nephrology Associates of Northern Virginia, Inc.

Fairfax, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Milwaukee Nephrologists, SC

Wauwatosa, Wisconsin, United States

John Hunter Hospital

New Lambton, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Melbourne Renal Research Group

Reservoir, Victoria, Australia

The Royal Melbourne Hospital

Parkville, , Australia

Chu Grenoble Alpes

Grenoble, , France

Hopital Necker, Universite Paris Descartes

Paris, , France

Japanese Red Cross Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Toranomon Hospital Kajigaya

Kawasaki, Kanagawa, Japan

St Marianna University Hospital

Kawasaki, Kanagawa, Japan

JCHO Sendai Hospital

Sendai, Miyagi, Japan

Kitano Hospital

Osaka, Osaka, Japan

Osaka University Hospital

Suita, Osaka, Japan

Saga University Hospital

Saga, Saga-ken, Japan

Saitama Children's Medical Center

Saitama-shi, Saitama, Japan

Juntendo University Hospital

Bunkyō-Ku, Tokyo, Japan

Jutendo University Hospital

Bunkyō-Ku, Tokyo, Japan

Tokyo Metropolitan Children's Medical Center

Fuchū, Tokyo, Japan

Toranomon Hospital

Minato-Ku, Tokyo, Japan

Tokyo Women's Medical University Hospital

Shinjuku-Ku, Tokyo, Japan

Niigata University Medical and Dental Hospital

Niigata, , Japan

Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital

Osaka, , Japan

Puerto Rico Clinical and Translational Research Consortium (PRCTRC)

Rio Piedras, , Puerto Rico

Fundacio Puigvert

Barcelona, Catalonia, Spain

Hospital Virgen de la Arrixaca

El Palmar, Murcia, Spain

Countries

United States; Australia; France; Japan; Puerto Rico; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-003253-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

402-C-1803

Identifier Type: -

Identifier Source: org_study_id