Rationale and design of an investigator-initiated, multicenter, prospective, placebo-controlled, double-blind, randomized trial to evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in type 2 diabetes and chronic kidney disease (FIVE-STAR)
Study context
- Population
- Patients with T2D and chronic kidney disease (CKD) (25 mL/min/1.73 m² ≤ eGFR < 90 mL/min/1.73 m² and 30 mg/g Cr ≤ UACR < 3500 mg/g Cr), Japantarget 100
- Planned comparison
- Finerenone vs dose-matched placebo for 24 weeks
- Primary endpoint
- Change from baseline in cardio ankle vascular index (CAVI)
- Follow-up
- 24 weeks
Methodological detailsrationale and design; ongoing, investigator-initiated, multicenter, prospective, placebo-controlled, double-blind, Recruitment September 2023 to July 2024, Equal randomisation, Secondary endpoints: changes in UACR at 12 and 24 weeks and serum and urinary biomarkers at 24 weeks; exploratory proteomic analysis (Olink® Target 96 panels)
- Rationale and design; ongoing
- Investigator-initiated
- Multicenter
- Prospective
- Placebo-controlled
- Double-blind
- Recruitment September 2023 to July 2024
- Equal randomisation
- Secondary endpoints: changes in UACR at 12 and 24 weeks and serum and urinary biomarkers at 24 weeks; exploratory proteomic analysis (Olink® Target 96 panels)
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and design of an investigator-initiated, multicenter, prospective, placebo-controlled, double-blind, randomized trial to evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in type 2 diabetes and chronic kidney disease (FIVE-STAR). Cardiovasc Diabetol. Published 31 July 2023. doi:10.
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