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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Disease, Type 2 Diabetes

Intervention / Treatment
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* Drug: RTA 402
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bardoxolone methyl<br>bardoxolone methyl capsules, dosage To Be Determined, once daily for 16 weeks | Drug: RTA 402<br> <br> |
| Placebo Comparator: Placebo<br>Placebo capsules, once daily for 16 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR | Change in eGFR from baseline to 16 weeks | Up to 16 weeks | 
| 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 | 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 | Baseline, week 2, 6, 10, and 4 weeks after completion of study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Diseases, Renal Insufficiency, Urologic Diseases, bardoxolone methyl, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Kidney Diseases, Renal Insufficiency, Chronic, Diabetes Complications, Endocrine System Diseases, Glucose Metabolism Disorders