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A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy

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Trial Profile

A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Jun 2025

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At a glance

  • Drugs Sparsentan (Primary) ; Irbesartan
  • Indications IgA nephropathy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PROTECT
  • Sponsors Travere Therapeutics

Most Recent Events

  • 03 Jun 2025 According to Travere Therapeutics Inc media release, abstracts from the trial will be presented at the upcoming European Renal Association (ERA) Congress in Vienna, Austria, June 4-7.
  • 23 May 2025 According to a CSL Vifor media release, Sparsentan must be funded in England within 90 days of final publication of the NICE recommendation which is expected to be 27 June 2025. CSL Vifor expects to launch sparsentan in the UK in 2H 2025.
  • 23 May 2025 According to a CSL Vifor media release, the National Institute for Health and Care Excellence (NICE) has recommended that sparsentan can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more. NICE has provided guidance to ensure that only patients responding to treatment continue.3 The decision follows authorisation from the UK's MHRA in April 2025.

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