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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.

Tracking Information
First Submitted Date  ICMJE November 27, 2014
First Posted Date  ICMJE December 15, 2014
Last Update Posted Date October 27, 2017
Study Start Date  ICMJE December 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2014)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2016)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2014)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study
Official Title  ICMJE RTA 402 Phase 2 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Chronic Kidney Disease and Type 2 Diabetes)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease
  • Type 2 Diabetes
Intervention  ICMJE
  • Drug: RTA 402
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: bardoxolone methyl
    bardoxolone methyl capsules, dosage To Be Determined, once daily for 16 weeks
    Intervention: Drug: RTA 402
  • Placebo Comparator: Placebo
    Placebo capsules, once daily for 16 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2017)
216
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2014)
72
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02316821
Other Study ID Numbers  ICMJE RTA 402-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyowa Kirin Co., Ltd.
Study Sponsor  ICMJE Kyowa Kirin Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kyowa Kirin Co., Ltd.
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP