Study of Lademirsen (SAR339375) in Patients With Alport Syndrome

  • STATUS
    Not Recruiting
  • End date
    Dec 4, 2023
  • participants needed
    45
  • sponsor
    Genzyme, a Sanofi Company
Updated on 9 May 2022

Summary

Primary Objectives:

  • To assess the efficacy of lademirsen (SAR339375) in reducing the decline in renal function
  • To assess the safety and tolerability of lademirsen (SAR339375) in subjects with Alport syndrome

Secondary Objectives:

  • To assess plasma pharmacokinetic (PK) parameters of the parent compound and its metabolites
  • To assess the potential formation of anti-drug antibodies (ADAs) following administration of lademirsen (SAR339375)
  • To assess the pharmacodynamic effect of lademirsen (SAR339375) on miR-21 and on changes in renal injury and function biomarkers.

Description

The planned length of participation in the study for each subject is up to approximately 110 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 ( all subject to enter a 48-week open label extension period and receive active treatment with lademirsen (SAR339375))
  • Post-treatment follow-up period of 10 weeks

Details
Condition Alport's Syndrome
Treatment Placebo, RG-012, SAR339375, Lademirsen (SAR339375)
Clinical Study IdentifierNCT02855268
SponsorGenzyme, a Sanofi Company
Last Modified on9 May 2022

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