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Multicenter, Open-label, Extension Study to Characterize the Long-term Efficacy and Safety of Early Versus Delayed Treatment With Venglustat (GZ/SAR402671) in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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Trial Profile

Multicenter, Open-label, Extension Study to Characterize the Long-term Efficacy and Safety of Early Versus Delayed Treatment With Venglustat (GZ/SAR402671) in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 31 Dec 2023

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At a glance

  • Drugs Venglustat (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Registrational; Therapeutic Use
  • Acronyms STAGED-PKD-EXT
  • Sponsors Sanofi
  • Most Recent Events

    • 03 Aug 2021 This trial has been completed in Netherlands, according to European Clinical Trials Database record.
    • 30 Jul 2021 This trial has been completed in Germany, according to European Clinical Trials Database record
    • 21 Jul 2021 Status changed from active, no longer recruiting to discontinued.(study was stopped after protocol specified interim analysis for futility of the Stage 1 of the EFC15392 study met the prespecified stopping rule based on the primary endpoint. )

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