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

Inclusion Criteria:

• Patients who are participating (or who have participated) in qualifying studies andwho have not been required to discontinue study treatment for protocol or safetyreasons and who have completed required End-of-Treatment and/or Follow-up visits in aprior clinical study with bardoxolone methyl and who, according to the assessment ofthe investigator, have a potential positive benefit-risk assessment for participatingin the trial.
• Meets the following eligibility criteria based on assessments from the priorqualifying study (last on-treatment visit) or from a screening visit, if applicable:

1. Not expected to reach end stage kidney disease (ESKD) or nephrotic syndromewithin 12 weeks of study enrollment, in the investigator's judgement; subjectswith eGFR <20 ml/min/1.73m2 should be discussed with the medical monitor beforeenrollment (e.g., such subjects with an average rate of eGFR decline > 1.0ml/min/1.73m2 per month in the 3 months prior to eligibility assessment may notbe eligible);
2. BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study orat a new screening visit, if applicable;
3. No occurrence of a cardiovascular serious adverse event in the prior qualifyingstudy or in the interval between the end of the qualifying study and thescreening 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 formif necessary) indicating that the patient (or a legally acceptable representative) hasbeen informed of all pertinent aspects of the study prior to initiation of anyprotocol-mandated procedures.

Exclusion Criteria:

• Participation in other investigational clinical studies involving interventionalproducts being tested or used in a way different from the approved form or when usedfor an unapproved indication;
• Patients who have an ongoing SAE from a clinical study that is assessed by theinvestigator as related to bardoxolone methyl;
• Unwilling to practice acceptable methods of birth control (both males who havepartners of childbearing potential and females of childbearing potential) whilescreening, 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 requirementsof the study protocol or is unsuitable for the study for any reason;
• Known hypersensitivity to any component of the study drug.