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Study of Lademirsen (SAR339375) in Patients With Alport Syndrome

NCT02855268 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-09-11

Study results available
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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 participants with Alport syndrome.

Secondary Objectives:

* To assess plasma pharmacokinetic (PK) parameters of the parent compound and its active major metabolite.
* 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.

Conditions

  • Alport Syndrome

Interventions

DRUG

lademirsen (SAR339375)

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

DRUG

Placebo

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-02
Primary Completion
2022-09-22
Completion
2022-09-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02855268 on ClinicalTrials.gov