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

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 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.

Timeline

Start

2018-05-30

Primary completion

2022-11-30

Completion

2023-07-31

Outcome

Mixed primary results

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.”

release “Kyowa Kirin has started a Phase III clinical study for the indication (AYAME study) in Japan from May 2018.” kyowakirin.com ↗

release “thereby meeting the primary and key secondary endpoints.” kyowakirin.com ↗

release “On the other hand, no difference in “Time to onset ESRD” between the two groups was observed.” kyowakirin.com ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bardoxolone methyl	Small molecule	5 mg	Oral
Subject	Bardoxolone methyl	Small molecule	10 mg	Oral
Subject	Bardoxolone methyl	Small molecule	15 mg	Oral

Indications