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A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd)

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A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Sep 2024

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At a glance

  • Drugs Budesonide (Primary)
  • Indications IgA nephropathy
  • Focus Registrational; Therapeutic Use
  • Acronyms NefIgArd
  • Sponsors Calliditas Therapeutics

    • Most Recent Events

    • 28 Aug 2024 According to an Everest Medicines media release, the European Commission has granted a full marketing authorization for Kinpeygo (the European trade name for NEFECON) for the treatment of adults with primary IgAN.
    • 28 Aug 2024 According to an Everest Medicines media release, National Medical Products Administration, China accepted the submission of a supplemental New Drug Application (sNDA) seeking full approval of NEFECON based on the complete clinical data from this study.
    • 28 Aug 2024 According to an Everest Medicines media release, in April 2024, the Hong Kong Department of Health approved NEFECON for the treatment of primary IgAN in adults at risk of disease progression. Commercial launch is expected in 2H 2024.

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