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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02316821
Recruitment Status : Completed
First Posted : December 15, 2014
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Type 2 Diabetes Drug: RTA 402 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: bardoxolone methyl
bardoxolone methyl capsules, dosage To Be Determined, once daily for 16 weeks
 Drug: RTA 402
Placebo Comparator: Placebo
Placebo capsules, once daily for 16 weeks
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Number and types of adverse events [ Time Frame: Up to 16 weeks ]
    Count of adverse events, by type, in the bardoxolone methyl arm compared to the placebo arm

  2. Change in glomerular filtration rate (GFR) measured by inulin clearance after 16 weeks of study drug administration, compared to baseline GFR [ Time Frame: Up to 16 weeks ]
    Change in GFR from baseline to 16 weeks


Secondary Outcome Measures :
  1. Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR [ Time Frame: Up to 16 weeks ]
    Change in eGFR from baseline to 16 weeks

  2. 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 [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316821


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
More Information
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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT02316821    
Other Study ID Numbers: RTA 402-005
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Keywords provided by Kyowa Kirin Co., Ltd.:
bardoxolone methyl
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
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency