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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Nephrology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:12 - 65
Updated:3/30/2019
Start Date:March 8, 2019
End Date:February 2024
Contact:Kyle Shotwell
Email:kyle.shotwell@reatapharma.com
Phone:469-442-4849

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An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease

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:

- Treatment-compliant patients who are participating in qualifying ongoing studies and
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 from the prior qualifying study. Patients not
meeting the following criteria may be eligible and must be discussed with the medical
monitor prior to enrollment to assess their current clinical status:

1. eGFR ≥ 30 mL/min/1.73 m2 at the last on-treatment visit in the prior qualifying
study;

2. BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study;

3. No occurrence of a cardiovascular serious adverse event in the prior qualifying
study.

- Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study 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 taking
study drug;

- 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.
We found this trial at
3
sites
Denver, Colorado 80230
Principal Investigator: Brad Marder, MD
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Denver, CO
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4620 Enterprise Way
Caldwell, Idaho 83605
Principal Investigator: Arnold L Silva, MD
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Caldwell, ID
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3525 East Louise Drive
Meridian, Idaho 83642
Principal Investigator: Arnold Silva, MD
Phone: 208-846-8335
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Meridian, ID
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