Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425055
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-05-14
Brief Title:
Vonafexor ALPort Syndrome Efficacy Safety TRIAl-1 ALPESTRIA-1
Sponsor:
Enyo Pharma
Organization:
Enyo Pharma
Study Overview
Official Title:
Vonafexor Fixed Dose-escalation Safety and Proof-of-concept Study in Patients With at Risk of Progression Alport Syndrome
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALPESTRIA-1
Brief Summary:
This study is a proof-of-concept trial of vonafexor safety its effects on kidney function in subjects with at risk of progression Alport syndrome
Detailed Description:
This is a multicenter study and several clinical sites and countries will be involved
This single arm fixed dose escalation open-label non-randomized study will evaluate three dose levels of vonafexor on safety tolerability and their effect on kidney function and renal biomarkers in 20 patients with AS at risk of progression
The total duration of study for a participant will be up to 40 weeks and include a screening period a treatment period of 24 weeks and a follow-up period of 12 weeks
This single arm fixed dose escalation open-label non-randomized study will evaluate three dose levels of vonafexor on safety tolerability and their effect on kidney function and renal biomarkers in 20 patients with AS at risk of progression
The total duration of study for a participant will be up to 40 weeks and include a screening period a treatment period of 24 weeks and a follow-up period of 12 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