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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Bardoxolone methyl capsules
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. AEs and SAEs that occurred within 30 days after the last dose were considered treatment-emergent. The study follow-up assessment was collected within 14 to 35 days after the last dose.
Time frame: From the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years)
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Apogee Clinical Research
Huntsville, Alabama, United States
Arizona Kidney Disease and Hypertension Research Services, PLLC
Glendale, Arizona, United States
Centricity Research Phoenix Multispecialty
Mesa, Arizona, United States
California Institute Renal Research
La Mesa, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Apex Research of Riverside
Riverside, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
University of California San Francisco - Children's Renal Center
San Francisco, California, United States
...and 77 more locations