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

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.

Criteria

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.