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