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

> **NCT03550443** · PHASE3 · TERMINATED · sponsor: **Kyowa Kirin Co., Ltd.** · enrollment: 1323 (actual)

## Conditions studied

- Diabetic Kidney Disease

## Interventions

- **DRUG:** Bardoxolone methyl
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT03550443
- **Lead sponsor:** Kyowa Kirin Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2018-05-30
- **Primary completion:** 2022-11-30
- **Final completion:** 2023-07-31
- **Target enrollment:** 1323 (ACTUAL)
- **Why 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.
- **Last updated:** 2023-09-26


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03550443

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03550443, "A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study". Retrieved via AI Analytics 2026-07-01 from https://api.ai-analytics.org/clinical/NCT03550443. Licensed CC0.

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