Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05887817
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-05-24
Brief Title:
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD FIVE-STAR
Sponsor:
Saga University
Organization:
Saga University
Study Overview
Official Title:
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in Type 2 Diabetes and Chronic Kidney Disease FIVE-STAR
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIVE-STAR
Brief Summary:
To evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in patients with type 2 diabetes and chronic kidney disease
Detailed Description:
Finerenone is a novel non-steroidal selective mineralocorticoid receptor antagonist MRA characterized by a higher selectivity and affinity for mineralocorticoid receptors than conventional steroidal MRA In the international phase III trials FIDELIO-DKD and FIGARO-DKD finerenone reduced the risk of progression of nephropathy and cardiovascular events in chronic kidney disease CKD patients with type 2 diabetes T2D who had been on standard treatment for CKD and T2D However the possible mechanistic insights into clinical benefits of finerenone in that patient population are currently very limited To address them in this investigator-initiated multicenter placebo-controlled randomized trial FIVE-STAR the investigators seek to assess the effects of finerenone on vascular stiffness and cardiorenal biomarkers in patients with T2D and CKD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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