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Diabetic Kidney DiseasePhase 3NCT03550443

A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study

A Phase 3 study testing Bardoxolone methyl in people with Diabetic Kidney Disease, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to demonstrate the efficacy of multiple oral doses of RTA 402 (5, 10, or 15 mg) administered once daily in patients with diabetic kidney disease (DKD) using the time to onset of a ≥ 30% decrease in estimated glomerular filtration rate calculated from serum creatinine (eGFR) from baseline… Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Diabetic Kidney Disease
What is being tested?
Bardoxolone methyl
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,323 participants
Where
1 siteJapan
Study dates
30 May 2018to 31 Jul 2023
Phase
Phase 3
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

  • Patients with DKD
  • Mean eGFR ≥ 15 and < 60 mL/min/1.73 m²
  • Albumin/creatinine ratio (ACR) ≤ 3500 mg/g Cr
  • Treatment with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) with no change in dosage or medication etc.

Who cannot join

  • Diabetes mellitus that is neither type 1 nor type 2
  • Decreased renal function mainly attributed to a non-diabetic cause
  • History of renal transplantation or upcoming preemptive renal transplantation
  • Confirmed mean systolic blood pressure > 160 mmHg or a confirmed mean diastolic blood pressure > 90 mmHg during the 8-week period before screening
  • Hemoglobin A1c level > 10.0% during screening
  • Serum albumin level ≤ 3.0 g/dL during screening
Show all 9Show fewer
  • Cardiovascular disease specified in the study protocol
  • History of cardiac failure
  • BNP level > 200 pg/mL during screening etc.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Japan Community Health care Organization Sendai Hospital

    Sendai, Miyagi, 981-3281

Other trials in Japan

About this study

Official title: RTA 402 Phase 3 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Diabetic Kidney Disease)

The purpose of this study is to demonstrate the efficacy of multiple oral doses of RTA 402 (5, 10, or 15 mg) administered once daily in patients with diabetic kidney disease (DKD) using the time to onset of a ≥ 30% decrease in estimated glomerular filtration rate calculated from serum creatinine (eGFR) from baseline or end-stage renal disease (ESRD) as an indicator in a randomized, double-blind, placebo-controlled study; the safety of RTA 402 will also be evaluated.

Being tested
Bardoxolone methyl, Placebo
Keywords
Bardoxolone Methyl, Diabetic Kidney Disease, Diabetes Mellitus, Kidney Diseases
Medical subject headings
Diabetic Nephropathies, Diabetes Mellitus, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bardoxolone methylDrug

    Also called RTA 402

    Bardoxolone methyl 5 mg capsules

  • PlaceboDrug

    Capsules containing an inert placebo

Study groups in NCT03550443
Study groupRoleWhat they receive
RTA 402(Bardoxolone methyl)ExperimentalPatients will receive multiple oral doses of bardoxolone methyl once daily. The starting dose of bardoxolone methyl will be 5 mg. The maximum dose will be 15 mg, and the dose will be increased by 5 mg.
Receives: Drug: Bardoxolone methyl
PlaceboPlacebo comparatorPatients randomized to placebo will remain on placebo throughout the study, undergoing sham titration.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRD

    Measured: Through double-blind part completion, approximately 3 to 4 years

Secondary outcomes (4)

  1. Time to onset of a ≥ 40% decrease in eGFR from baseline or ESRD

    Measured: Through double-blind part completion, approximately 3 to 4 years

  2. Time to onset of a ≥ 53% decrease in eGFR from baseline or ESRD

    Measured: Through double-blind part completion, approximately 3 to 4 years

  3. Time to onset of ESRD

    Measured: Through double-blind part completion, approximately 3 to 4 years

  4. Change in eGFR from baseline at each evaluation time point

    Measured: Through double-blind part completion, approximately 3 to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2018
  2. Study start30 May 2018
  3. Primary completion30 Nov 2022
  4. Study completion31 Jul 2023

Why it stopped: Based on results of double-blind parts, it was determined that it would be difficult to submit a marketing authorization application for RTA 402 for diabetic kidney disease.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized double-blinded part followed by open label extension part.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,323 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03550443
Sponsor's protocol ID
RTA 402-006
Status last verified
Sep 2023
First submitted
14 May 2018
Last updated
26 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 40498549

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bardoxolone methyl in people with Diabetic Kidney Disease, 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 26 Sep 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Based on results of double-blind parts, it was determined that it would be difficult to submit a marketing authorization application for RTA 402 for diabetic kidney disease.). Results are not available in the source record.

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?

Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRD (time frame: Through double-blind part completion, approximately 3 to 4 years). 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 NCT03550443, which also lists 1 linked publication.

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 26 Sep 2023.

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