Effects of finerenone on arterial stiffness and cardiorenal biomarkers in patients with type 2 diabetes and chronic kidney disease: a randomised placebo-controlled mechanistic trial (FIVE-STAR)
Authors' conclusion
Finerenone did not affect changes in vascular stiffness but led to a significant and sustained reduction in albuminuria in patients with T2D and CKD. The clinical benefits of finerenone may result from lowering intraglomerular pressure rather than from its effect on vascular stiffness.
Study context
- Population
- Patients with T2D and chronic kidney disease (CKD) (eGFR 25 to <90 mL/min/1.73 m²; UACR 30 to <3500 mg/g Cr), 13 sites in Japan101 analysed
- Participants
- 102 patients
- Comparison
- Dose-adjusted finerenone vs placebo
- Primary endpoint
- Change in cardio-ankle vascular index (CAVI)
- Follow-up
- Week 24
Methodological detailsinvestigator-initiated, multicentre, prospective, two-arm parallel, placebo-controlled, double-blind, mechanistic
- Investigator-initiated
- Multicentre
- Prospective
- Two-arm parallel
- Placebo-controlled
- Double-blind
- Mechanistic
Primary result
Change in CAVI
Group difference
- 0.057
95% CI - 0.428 to 0.314
P = 0.760
Change by group
Finerenone
- 0.023
95% CI - 0.299 to 0.254
Placebo
0.011
95% CI - 0.245 to 0.267
As reported in the abstract
Secondary outcomes
| Outcome | Group ratio (95% CI) | P value |
|---|---|---|
| UACR (key secondary endpoint) · week 1229% reduction with finerenone | 0.706 (0.504–0.989) | P = 0.043 |
| UACR (key secondary endpoint) · week 2429% reduction with finerenone | 0.709 (0.506–0.994) | P = 0.046 |
Circulating proteins (exploratory, Olink panels)
- Proteins with nominal changes in expression with finerenone vs placebo, of 181 tested
- 11
- Exploratory analysis
Safety
eGFR and urinary biomarkers of acute tubular injury · over 24 weeks
- Early and sustained eGFR decline with finerenone, without increased urinary biomarkers of acute tubular injury
Original publication
Effects of finerenone on arterial stiffness and cardiorenal biomarkers in patients with type 2 diabetes and chronic kidney disease: a randomised placebo-controlled mechanistic trial (FIVE-STAR). Cardiovasc Diabetol. Published 5 December 2025. doi:10.
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