The Phase II Study of Bardoxolone Methyl in Patients with Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study
Phase 2
- Conditions
- CKD patients with type 2 diabetes
- Registration Number
- JPRN-jRCT2080222666
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
CKD patients with type 2 diabetes mellitus
-Patients whose eGFR levels are eligible for this study
-Patients being treated with stable dose of ACE inhibitors and/or 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 SBP > 160 mmHg or DBP > 90 mmHg
-Patients with HbA1c > 10%
-Patients with cardiovascular disease specified in the study protocol etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br><br>aderse events <br>Efficacy<br><br>Changes in GFR from baseline to week 16
- Secondary Outcome Measures
Name Time Method Efficacy<br>Change in eGFR from baseline to week 16<br>Pharmacokinetics<br>Plasma level of RTA 402