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

Stopped early · Phase 3

Conditions studied: Chronic Kidney Diseases, Alport Syndrome, Autosomal Dominant Polycystic Kidney

In brief

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.

Key facts

Study ID

NCT03749447

Run by

Biogen

People needed

270

Starts

2019-03-08

Expected to finish

2023-08-23

Last updated by the study team

2025-06-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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