Ignite Creation Date:
2024-05-06 @ 8:54 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02855268
Status:
TERMINATED
Last Update Posted:
2023-10-23
First Post:
2016-07-28
Brief Title:
Study of Lademirsen SAR339375 in Patients With Alport Syndrome
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety Efficacy Pharmacodynamics and Pharmacokinetics of Lademirsen SAR339375 for Subcutaneous Injection Administered Every Week in Patients With Alport Syndrome
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The results of the futility analysis led to the study termination No unexpected safety findings were identified
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HERA
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
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
Screeningbaseline 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
Screeningbaseline 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-004394-10 | EUDRACT_NUMBER | None | None |