This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial
will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients
Patients will be randomized 1:1 to either bardoxolone methyl or placebo. Patients receiving
bardoxolone methyl will start with once-daily dosing at 5 mg and will dose-escalate to 10 mg
at Week 2, to 20 mg at Week 4, and then to 30 mg at Week 6 (only if baseline ACR >300 mg/g)
unless contraindicated clinically and approved by the medical monitor. Dose de-escalation is
permitted during the study if indicated clinically, and subsequent dose re-escalation is also
permitted to meet the dosing objective of the highest tolerated dose.
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, 12, 24, 36, 48, 52, 64, 76, 88, 100, and 104 and by telephone contact on Days
3, 10, 21, 31, 38, and 45. Patients will not receive study drug during a 4-week withdrawal
period between Weeks 48 and 52. They will re-start treatment at Week 52 at the same dose they
received at Week 48 and will continue study drug treatment through Week 100. Patients will
also be scheduled to be assessed at an in-person follow-up visit at Week 104, four weeks
after the end of treatment.