The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study

RTA 402 Phase 2 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Chronic Kidney Disease and Type 2 Diabetes)

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.

Inclusion Criteria:

• CKD patients with type 2 diabetes mellitus
• Patients whose estimated GFR levels are eligible for this study
• Patients being treated with stable dose of angiotensin converting enzyme (ACE) inhibitors and/or angiotensin II receptor blocker (ARB) etc.

Exclusion Criteria:

• Patients with type 1 diabetes mellitus
• Patients with known non-diabetic renal disease
• Patients with a history of renal transplantation
• Patients with mean systolic blood pressure > 160 mmHg or diastolic blood pressure > 90 mmHg
• Patients with Hemoglobin A1c > 10%
• Patients with cardiovascular disease specified in the study protocol etc.