This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). Patients will be enrolled in disease specific cohorts within the trial, and effectiveness of bardoxolone methyl in treating CKD will be assessed separately by cohort for each rare CKD. All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 1, 2, 4, 6, 8, and 12, and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients will also be scheduled to be assessed at an in-person follow-up visit at Week 16, four weeks after the end of treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Bardoxolone 5 mg capsules
University of Alabama Birmingham
Birmingham, Alabama, United States
Phoenician Centers for Research & Innovation (PCRI)
Phoenix, Arizona, United States
University of California Los Angeles
Los Angeles, California, United States
Denver Nephrology
Denver, Colorado, United States
Gulfcoast Endocrine and Diabetes Center
Clearwater, Florida, United States
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12
To assess the change in eGFR from baseline to week 12. eGFR is a measure of kidney function assessed through blood/serum. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function.
Time frame: 12 weeks after participant receives the first dose
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South Florida Research Institute
Lauderdale Lakes, Florida, United States
Coastal Nephrology Associates
Port Charlotte, Florida, United States
Kidney Care Augusta
Augusta, Georgia, United States
Boise Kidney & Hypertension, PLLC
Caldwell, Idaho, United States
Boise Kidney & Hypertension, PLLC
Meridian, Idaho, United States
...and 20 more locations