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Title An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease
Therapeutic Area Polycystic Kidney Disease
Principal Investigator Ronald Perrone, MD
Min Age 18 Years
Gender Any
Contact Nicole Merullo
More Information


To provide continuing open-label treatment with bardoxolone methyl as part of this extended access program while collecting ongoing safety and tolerability data of bardoxolone methyl.

Study Details

Inclusion Criteria

1. Patients who are participating (or who have participated in qualifying Bardoxolone Methyl studies who have not needed to stop study medication for safety reasons and will potentially benefit from extended use of the study medication.
2. Meets the following based on last visit in prior qualifying trial or at screening visit:
a. Not expected to reach end stage kidney disease (ESKD) or nephrotic syndrome within 12 weeks of study enrollment, in the investigator’s judgement
b. BNP < 200 pg/mL
c. No occurrence of a cardiovascular serious adverse event

Exclusion Criteria

1. Experiencing an ongoing serious adverse event that the investigator has decided is related to Bardoxolone Methyl
2. Patients who are pregnant, breastfeeding, or unwilling/unable to use acceptable birth control methods while in the study and for 30 days after.

Study Requirements

All patients in the study will follow the same visit and assessment schedule. Patients will be scheduled to be assessed in person during treatment at Day 1, Weeks 1, 2, 4, 6, 8, 12, 24, and every 24 weeks thereafter. Patients will also be assessed by telephone contact on Days 3, 10, 21, 31, 38, and 45. Day 1 for this trial can occur as early as the last visit of the prior qualifying study, but if not there is a screening visit that can re-qualify a patient who had a gap in treatment. Each in-person visit would require a blood draw, physical, vitals and urine sample. Each in person visit should last 60 to 90 min.