This study is a multi-center, double-blinded, randomized, study of bardoxolone methyl treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus (T2DM) on peritoneal dialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Oral, once daily
Oral, once daily
Number of Adverse Events
Time frame: Approximately 17 months
Type of Adverse Events
Time frame: Approximately 17 months
Change in Residual Renal Function
Time frame: Baseline to 6 months
Maximum observed concentration
Time frame: Day 0, 30, 60, 90, 120, 150, 180, 210
Time to maximum observed concentration
Time frame: Day 0, 30, 60, 90, 120, 150, 180, 210
Area under the plasma concentration-time curve
Only the first 8 patients randomized will have the PK drawn and hours 2, 4, 8, and 24. All patients will have the PK drawn at 30, 60, 90, 120, 150 and 180 days.
Time frame: 2, 4, 8, 24 hours, 30, 60, 90, 120, 150 and 180 days
Area under the curve
Only the first 8 patients randomized
Time frame: 2, 4, 8 and 24 hours
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