Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT02855268
Brief 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.
Detailed Description:
The planned length of participation in the study for each participant was up to approximately 110 weeks (from screening through completion of follow-up). This included:
* 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 participant to enter a 48-week open label extension period and receive active treatment with lademirsen \[SAR339375\]).
* Post-treatment follow-up period of 10 weeks.
Study:
NCT02855268
Study Brief:
Protocol Section:
NCT02855268