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Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Trial Profile

Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 21 Sep 2023

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At a glance

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

    • 01 May 2023 Primary results of prespecified interim futility analysis assessing efficacy of Venglustat in patients at risk of rapidly progressing Autosomal dominant polycystic kidney disease, published in the American Journal of Kidney Diseases.
    • 29 Aug 2021 This trial has been completed in Netherland (End Date: 03 Aug 2021), according to European Clinical Trials Database record.
    • 15 Aug 2021 This trial has been completed in Denmark, according to European Clinical Trials Database record.
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