Study of SAR339375 in Patients With Alport Syndrome

  • STATUS
    Recruiting
  • participants needed
    45
  • sponsor
    Genzyme, a Sanofi Company
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Updated on 19 February 2024
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Summary

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

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

Details
Condition Collagen disease, collagen vascular diseases, Alport's Syndrome, Nephritis, Nephritis, collagen vascular diseases
Age 18years - 55years
Treatment Placebo, Lademirsen (SAR339375)
Clinical Study IdentifierNCT02855268
SponsorGenzyme, a Sanofi Company
Last Modified on19 February 2024

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