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

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease; Type 2 Diabetes

Treatments: Drug: Placebo; Drug: RTA 402

Study type: Interventional

Funder types: Industry

Identifiers

NCT02316821

RTA 402-005

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups, including a placebo group

bardoxolone methyl

Experimental group

Description:

bardoxolone methyl capsules, dosage To Be Determined, once daily for 16 weeks

Treatment:

Drug: RTA 402

Placebo

Placebo Comparator group

Description:

Placebo capsules, once daily for 16 weeks

Treatment:

Drug: Placebo