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A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function

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

Latest Information Update: 07 Apr 2025

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At a glance

  • Drugs Atrasentan (Primary)
  • Indications IgA nephropathy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ALIGN
  • Sponsors Chinook Therapeutics

Most Recent Events

  • 02 Apr 2025 According to a Novartis media release, the company announced that the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia (atrasentan).The continued approval of Vanrafia may be contingent upon the verification of clinical benefit from the this study evaluating whether Vanrafia slows disease progression as measured by estimated glomerular filtration rate (eGFR) decline at week 1361. The eGFR data are expected in 2026 and intended to support traditional FDA approval
  • 20 Mar 2025 According to a Novartis media release, the company announced that a decision on FDA filling is anticipated in H1 2025.
  • 27 Oct 2024 According to a Novartis media release, atrasentan received FDA filing acceptance in Q2 2024.

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