Back to resultsThe Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study
Primary Purpose
Chronic Kidney Disease, Type 2 Diabetes
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
RTA 402
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Kidney Diseases, Renal Insufficiency, Chronic, Diabetes Complications, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Renal Insufficiency, Urologic Diseases, bardoxolone methyl
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
bardoxolone methyl
Placebo
Arm Description
bardoxolone methyl capsules, dosage To Be Determined, once daily for 16 weeks
Placebo capsules, once daily for 16 weeks
Outcomes
Primary Outcome Measures
Safety: Number and types of adverse events
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
Change in GFR from baseline to 16 weeks
Secondary Outcome Measures
Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR
Change in eGFR from baseline 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
Full Information
NCT ID
NCT02316821
First Posted
November 27, 2014
Last Updated
October 26, 2017
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02316821
Brief Title
The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study
Official Title
RTA 402 Phase 2 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Chronic Kidney Disease and Type 2 Diabetes)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Type 2 Diabetes
Keywords
Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Kidney Diseases, Renal Insufficiency, Chronic, Diabetes Complications, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Renal Insufficiency, Urologic Diseases, bardoxolone methyl
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bardoxolone methyl
Arm Type
Experimental
Arm Description
bardoxolone methyl capsules, dosage To Be Determined, once daily for 16 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules, once daily for 16 weeks
Intervention Type
Drug
Intervention Name(s)
RTA 402
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety: Number and types of adverse events
Description
Count of adverse events, by type, in the bardoxolone methyl arm compared to the placebo arm
Time Frame
Up to 16 weeks
Title
Change in glomerular filtration rate (GFR) measured by inulin clearance after 16 weeks of study drug administration, compared to baseline GFR
Description
Change in GFR from baseline to 16 weeks
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR
Description
Change in eGFR from baseline to 16 weeks
Time Frame
Up to 16 weeks
Title
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
Description
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
Time Frame
Baseline, week 2, 6, 10, and 4 weeks after completion of study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study
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