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

Overview

About this study

The purpose of this study is to 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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/1.73m^2 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.

Eligibility last updated 7/13/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Vicente Torres, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions