Last reviewed · How we verify

NCT03550443

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

Terminated Phase 3 Last updated 26 September 2023
What this trial tests

Phase 3 trial testing Bardoxolone methyl in Diabetic Kidney Disease in 1,323 participants. Terminated before completion.

Timeline
30 May 2018
Primary endpoint
30 November 2022
31 July 2023

Quick facts

Lead sponsorKyowa Kirin Co., Ltd.
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment1,323
Start date30 May 2018
Primary completion30 November 2022
Estimated completion31 July 2023
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Kyowa Kirin Co., Ltd. — full company profile →

Who can join

Adults 20 to 79, any sex, with Diabetic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pathogenic Pathways and Therapeutic Approaches Targeting Inflammation in Diabetic Nephropathy.
    Rayego-Mateos S, Morgado-Pascual JL, Opazo-Ríos L, Guerrero-Hue M, et al · · 2020 · cited 237× · PMID 32471207 · DOI 10.3390/ijms21113798
  2. The KEAP1-NRF2 System as a Molecular Target of Cancer Treatment.
    Taguchi K, Yamamoto M. · · 2020 · cited 140× · PMID 33375248 · DOI 10.3390/cancers13010046
  3. Oxidative Stress and NRF2/KEAP1/ARE Pathway in Diabetic Kidney Disease (DKD): New Perspectives.
    Tanase DM, Gosav EM, Anton MI, Floria M, et al · · 2022 · cited 125× · PMID 36139066 · DOI 10.3390/biom12091227
  4. Roles of Nrf2 in Protecting the Kidney from Oxidative Damage.
    Nezu M, Suzuki N. · · 2020 · cited 121× · PMID 32331329 · DOI 10.3390/ijms21082951
  5. Oxidative Stress: A Culprit in the Progression of Diabetic Kidney Disease.
    Wang N, Zhang C. · · 2024 · cited 95× · PMID 38671903 · DOI 10.3390/antiox13040455
  6. Nrf2: The Master and Captain of Beta Cell Fate.
    Baumel-Alterzon S, Katz LS, Brill G, Garcia-Ocaña A, et al · · 2021 · cited 81× · PMID 33243626 · DOI 10.1016/j.tem.2020.11.002
  7. Current Landscape of NRF2 Biomarkers in Clinical Trials.
    Yagishita Y, Gatbonton-Schwager TN, McCallum ML, Kensler TW. · · 2020 · cited 81× · PMID 32784785 · DOI 10.3390/antiox9080716
  8. Protective Role of Nrf2 in Renal Disease.
    Guerrero-Hue M, Rayego-Mateos S, Vázquez-Carballo C, Palomino-Antolín A, et al · · 2020 · cited 74× · PMID 33396350 · DOI 10.3390/antiox10010039

Verify or expand the search:

Other trials of Bardoxolone methyl

Trials testing the same drug.

Other recruiting trials for Diabetic Kidney Disease

Currently open trials in the same condition.

Other Kyowa Kirin Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03550443.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing