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

October 26, 2017 updated by: Kyowa Kirin Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Up to 16 weeks
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
Time Frame: Up to 16 weeks
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
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
Baseline, week 2, 6, 10, and 4 weeks after completion of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

December 12, 2014

First Posted (Estimate)

December 15, 2014

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTA 402-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe