The purpose of this study is to assess the safety and efficacy of RTA 402 in chronic kidney disease (CKD) patients with type 2 diabetes in a double-blind, placebo-controlled study when this compound is administered once daily for 16 weeks in an intrapatient dose escalation design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
216
Unnamed facility
Tokyo, Japan
Safety: Number and types of adverse events
Count of adverse events, by type, in the bardoxolone methyl arm compared to the placebo arm
Time frame: Up to 16 weeks
Change in glomerular filtration rate (GFR) measured by inulin clearance after 16 weeks of study drug administration, compared to baseline GFR
Change in GFR from baseline to 16 weeks
Time frame: Up to 16 weeks
Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR
Change in eGFR from baseline to 16 weeks
Time frame: Up to 16 weeks
Profiles of pharmacokinetics of plasma RTA 402 concentration: Trough (Pre-dose) and peak (2-4 hours post dose) concentrations of study drug at steady state
Relationship between the study drug dose and the trough (Pre-dose) and peak (2-4 hours post dose) concentrations of study drug at steady state
Time frame: Baseline, week 2, 6, 10, and 4 weeks after completion of study treatment
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