deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT03550443

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

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

Sponsor: Kyowa Kirin Co., Ltd.

Conditions Diabetic Kidney Disease
Interventions Bardoxolone methyl Placebo
Updated 12 times since 2018 Last updated: Sep 22, 2023 Started: May 30, 2018 Primary completion: Nov 30, 2022 Completion: Jul 31, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

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.

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This PHASE3 trial investigates Diabetic Kidney Disease and is currently terminated or withdrawn. Kyowa Kirin Co., Ltd. leads this study, which shows 12 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jul 2018 – ~Jan 2019 · 6 months · monthly snapshotRecruiting~Jan 2019 – ~Apr 2019 · 3 months · monthly snapshotRecruiting~Apr 2019 – ~Aug 2019 · 4 months · monthly snapshotRecruiting~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshotRecruiting~Sep 2019 – ~Oct 2020 · 13 months · monthly snapshotActive Not Recruiting~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotActive Not Recruiting~Sep 2021 – ~Jul 2022 · 10 months · monthly snapshotActive Not Recruiting~Jul 2022 – ~Oct 2023 · 15 months · monthly snapshotActive Not Recruiting~Oct 2023 – ~Jul 2024 · 9 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 24 months · monthly snapshotTerminated

Change History

12 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  3. Oct 2023 — Jul 2024 [monthly]

    Terminated PHASE3

    Status: Active Not Recruiting → Terminated

  4. Jul 2022 — Oct 2023 [monthly]

    Active Not Recruiting PHASE3

  5. Sep 2021 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

▶ Show 7 earlier versions

  1. Jan 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  2. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  3. Sep 2019 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  4. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  5. Apr 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  6. Jan 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  7. Jul 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

    First recorded

May 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Kyowa Kirin Co., Ltd.
Data source: Kyowa Kirin Co., Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations