Last updated on February 2020

Study of SAR339375 in Patients With Alport Syndrome

Brief description of study

Primary Objectives:

  • To assess the efficacy of SAR339375 in reducing the decline in renal function
  • To assess the safety and tolerability of SAR339375

Secondary Objectives:

  • To assess plasma pharmacokinetic (PK) parameters of the parent compound and its metabolites
  • To assess the immunogenicity of the SAR339375

Detailed Study Description

The planned length of participation in the study for each subject is up to approximately 106 weeks (from screening through completion of follow-up). This includes:

  • Screening/baseline period of up to 4 weeks
  • Double-blind, placebo-controlled treatment period of 48 weeks
  • Open-label extension treatment period of 48 weeks ( opportunity for all subject to enter a 48-week open label extension period and receive active treatment with SAR339375)
  • Post-treatment follow-up period of 6 weeks

Clinical Study Identifier: NCT02855268

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