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

Phase 2

Completed

• Conditions: Chronic Kidney Disease; Type 2 Diabetes
• Interventions: Drug: RTA 402; Drug: Placebo

• Registration Number: NCT02316821
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-27
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-12
• Study First Posted: 2014-12-15
• Primary Completion: 2016-05
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bardoxolone methyl	RTA 402	bardoxolone methyl capsules, dosage To Be Determined, once daily for 16 weeks
Placebo	Placebo	Placebo capsules, once daily for 16 weeks

Primary Outcome Measures

Name	Time	Method
Safety: Number and types of adverse events	Up to 16 weeks	Count of adverse events, by type, in the bardoxolone methyl arm compared to the placebo arm
Change in glomerular filtration rate (GFR) measured by inulin clearance after 16 weeks of study drug administration, compared to baseline GFR	Up to 16 weeks	Change in GFR from baseline to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Profiles of pharmacokinetics of plasma RTA 402 concentration: Trough (Pre-dose) and peak (2-4 hours post dose) concentrations of study drug at steady state	Baseline, week 2, 6, 10, and 4 weeks after completion of study treatment	Relationship between the study drug dose and the trough (Pre-dose) and peak (2-4 hours post dose) concentrations of study drug at steady state
Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR	Up to 16 weeks	Change in eGFR from baseline to 16 weeks