Study of Lademirsen (SAR339375) in Patients With Alport Syndrome
Status:
Recruiting
Trial end date:
2023-12-04
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Genzyme, a Sanofi Company Regulus Therapeutics Inc.