The primary efficacy endpoint for CARDINAL is change from baseline in eGFR in bardoxolone methyl-treated patients relative to placebo after 48 and 100 weeks of treatment. Key secondary endpoints were the off-treatment changes from baseline in eGFR at weeks 52 and 104, following a 4-week withdrawal period.

Several exploratory endpoints at the 48- and 100-week time points will also be considered: (1) the proportion of patients who experienced either a 30% increase or decrease from baseline in eGFR; (2) the distribution of changes in eGFR from baseline; (3) Patient Global Impression of Change (PGIC) and Clinical Global Impression-Improvement (CGI-I) scores after 48 and 100 weeks of treatment; and (4) the proportion of patients with a kidney failure event defined as the composite endpoint consisting of confirmed ≥30% decline from baseline in eGFR, confirmed eGFR <15 mL/min/1.73 m2, or ESKD (initiation of maintenance dialysis or kidney transplant).

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