Chronic Kidney DiseasePhase 2NCT02316821
The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study
A Phase 2 study testing RTA 402 in people with Chronic Kidney Disease and Type 2 Diabetes, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Chronic Kidney Disease, Type 2 Diabetes
- What is being tested?
- RTA 402
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2014to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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)
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.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Being tested
- RTA 402, Placebo
- 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
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Diabetes Mellitus, Diabetic Nephropathies, Kidney Diseases, Diabetes Complications, Endocrine System Diseases, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTA 402Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| bardoxolone methyl | Experimental | bardoxolone methyl capsules, dosage To Be Determined, once daily for 16 weeks Receives: Drug: RTA 402 |
| Placebo | Placebo comparator | Placebo capsules, once daily for 16 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number and types of adverse events
Count of adverse events, by type, in the bardoxolone methyl arm compared to the placebo arm
Measured: 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
Measured: Up to 16 weeks
Secondary outcomes (2)
Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR
Change in eGFR from baseline to 16 weeks
Measured: 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
Measured: Baseline, week 2, 6, 10, and 4 weeks after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316821
- Sponsor's protocol ID
- RTA 402-005
- Status last verified
- Oct 2017
- First submitted
- 27 Nov 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoshioka K, Kaneko H, Haruyama W, Tomiyama T, Takami A, Kitayama T, Yamasaki K. Multi-Omics Reveal Antioxidant Effects of Bardoxolone Methyl in the Phase 2 Study of Bardoxolone Methyl in Patients with CKD and Type 2 Diabetes Study. Kidney360. 2025 Nov 1;6(11):1880-1889. doi: 10.34067/KID.0000000853. Epub 2025 Jun 11.
PubMed 40498549Mwesigwa N, Millar Vernetti P, Kirabo A, Black B, Ding T, Martinez J, Palma JA, Biaggioni I, Kaufmann H, Shibao CA. Atomoxetine on neurogenic orthostatic hypotension: a randomized, double-blind, placebo-controlled crossover trial. Clin Auton Res. 2024 Dec;34(6):561-569. doi: 10.1007/s10286-024-01051-2. Epub 2024 Sep 19.
PubMed 39294522Ikejiri K, Suzuki T, Muto S, Takama H, Yamawaki K, Miyazawa T, Urakawa I, Aoki Y, Otsuki A, Katsuoka F, Kinoshita K, Nangaku M, Akizawa T, Yamamoto M. Effects of NRF2 polymorphisms on safety and efficacy of bardoxolone methyl: subanalysis of TSUBAKI study. Clin Exp Nephrol. 2024 Mar;28(3):225-234. doi: 10.1007/s10157-023-02427-w. Epub 2023 Nov 14.
PubMed 37962746
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02316821
- Acronym / sponsor ID
- RTA 402-005
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bardoxolone methyl | Experimental | Drug: RTA 402bardoxolone methyl capsules, dosage To Be Determined, once daily for 16 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules, once daily for 16 weeks |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RTA 402 | Drug | bardoxolone methyl |
| Placebo | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 40498549Yoshioka K, Kaneko H, Haruyama W, Tomiyama T, Takami A, Kitayama T, Yamasaki K. Multi-Omics Reveal Antioxidant Effects of Bardoxolone Methyl in the Phase 2 Study of Bardoxolone Methyl in Patients with CKD and Type 2 Diabetes Study. Kidney360. 2025 Nov 1;6(11):1880-1889. doi: 10.34067/KID.0000000853. Epub 2025 Jun 11.
- Derived from this study: PubMed 39294522Mwesigwa N, Millar Vernetti P, Kirabo A, Black B, Ding T, Martinez J, Palma JA, Biaggioni I, Kaufmann H, Shibao CA. Atomoxetine on neurogenic orthostatic hypotension: a randomized, double-blind, placebo-controlled crossover trial. Clin Auton Res. 2024 Dec;34(6):561-569. doi: 10.1007/s10286-024-01051-2. Epub 2024 Sep 19.
- Derived from this study: PubMed 37962746Ikejiri K, Suzuki T, Muto S, Takama H, Yamawaki K, Miyazawa T, Urakawa I, Aoki Y, Otsuki A, Katsuoka F, Kinoshita K, Nangaku M, Akizawa T, Yamamoto M. Effects of NRF2 polymorphisms on safety and efficacy of bardoxolone methyl: subanalysis of TSUBAKI study. Clin Exp Nephrol. 2024 Mar;28(3):225-234. doi: 10.1007/s10157-023-02427-w. Epub 2023 Nov 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RTA 402 in people with Chronic Kidney Disease and Type 2 Diabetes, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number and types of adverse events (time frame: Up to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02316821, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.