The purpose of this study is to demonstrate the efficacy of multiple oral doses of RTA 402 (5, 10, or 15 mg) administered once daily in patients with diabetic kidney disease (DKD) using the time to onset of a ≥ 30% decrease in estimated glomerular filtration rate calculated from serum creatinine (eGFR) from baseline or end-stage renal disease (ESRD) as an indicator in a randomized, double-blind, placebo-controlled study; the safety of RTA 402 will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,323
Bardoxolone methyl 5 mg capsules
Capsules containing an inert placebo
Japan Community Health care Organization Sendai Hospital
Sendai, Miyagi, Japan
Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRD
Time frame: Through double-blind part completion, approximately 3 to 4 years
Time to onset of a ≥ 40% decrease in eGFR from baseline or ESRD
Time frame: Through double-blind part completion, approximately 3 to 4 years
Time to onset of a ≥ 53% decrease in eGFR from baseline or ESRD
Time frame: Through double-blind part completion, approximately 3 to 4 years
Time to onset of ESRD
Time frame: Through double-blind part completion, approximately 3 to 4 years
Change in eGFR from baseline at each evaluation time point
Time frame: Through double-blind part completion, approximately 3 to 4 years
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