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A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome

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Trial Profile

A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 07 Feb 2024

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At a glance

  • Drugs Bardoxolone methyl (Primary)
  • Indications Hereditary nephritis
  • Focus Registrational; Therapeutic Use
  • Acronyms CARDINAL
  • Sponsors Reata Pharmaceuticals

    • Most Recent Events

    • 01 Dec 2022 Results evaluating the safety and efficacy of bardoxolone methyl in patients with Alport syndrome, published in the Clinical Journal of The American Society of Nephrology: CJASN
    • 28 Feb 2022 According to a Reata Pharmaceuticals media release, On February 25, 2022, the company received a complete response letter from the FDA with respect to its review of NDA for bardoxolone in the treatment of patients with chronic kidney disease caused by Alport syndrome.
    • 08 Dec 2021 According to a Reata Pharmaceuticals media release, Kyowa Kirin submitted an NDA in Japan to the Ministry of Health, Labour and Welfare for bardoxolone for improvement of renal function in patients with Alport syndrome, and the application is currently under review.

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