This multi-center, randomized, double-blind, placebo-controlled, Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with CKD due to multiple etiologies at risk of rapid disease progression. Approximately 70 patients will be enrolled and randomized 1:1 to either bardoxolone methyl or placebo. Patients with CKD secondary to varying etiologies will be enrolled from age 18-70 years with eGFR ≥ 20 to \< 60 mL/min/1.73 m2, and other risk factors for rapid progression of kidney disease. The maximum target dose will be determined by baseline proteinuria status. Patients with baseline urine albumin to creatinine ratio (UACR) ≤ 300 mg/g will be titrated to a maximum dose of 20 mg, and patients with baseline UACR \> 300 mg/g will be titrated to a maximum dose of 30 mg. Qualified patients will be randomized 1:1 to receive either bardoxolone methyl or placebo once daily (preferably in the morning) throughout a 12-week dosing period. Patients in the study will follow the same visit and assessment schedule. Patients will be assessed during treatment at Day 1, Weeks 1, 2, 4, 6, 8, and 12 and by telephone contact on Days 3, 10, 21, 31, 35, and 45. Date of last dose and the end-of-treatment assessments mark the end of the treatment period. Patients will not receive study drug during a 5-week off-treatment period between Weeks 12 and 17. The off-treatment (OT) period includes 5 visits requiring various assessments to characterize eGFR from the time of study drug discontinuation through Day 35 off-treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
81
Bardoxolone methyl capsules dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status
Capsule containing an inert placebo
California Institute of Renal Research
La Mesa, California, United States
Western Nephrology
Arvada, Colorado, United States
Colorado Kidney Care
Denver, Colorado, United States
Boise Kidney & Hypertension, PLLC
Nampa, Idaho, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States
Nephrology Center, PC
Kalamazoo, Michigan, United States
DaVita Clinical Research
Las Vegas, Nevada, United States
Columbia Nephrology Associates, PA
Columbia, South Carolina, United States
Renal Disease Research Intitute
Dallas, Texas, United States
DaVita Clinical Research
Houston, Texas, United States
...and 2 more locations
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: Baseline through 12 weeks after participant receives the first dose
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