To evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in patients with type 2 diabetes and chronic kidney disease.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Study participants will be instructed to take either finerenone or placebo orally once daily (preferably at approximately the same time every during the morning). For study participants with baseline eGFR less than 60mL/min/1.73 m2, the starting dose will be 10mg/day of finerenone (equivalent to 10mg/day in the placebo group), followed by 20 mg/day (equivalent to 20mg/day in the placebo group) approximately 4 weeks after the first dose, in accordance with the latest package insert. The dose should be increased to 20mg/day (equivalent to 20mg/day in the placebo group) in principle after 4 weeks from the start of the first dose, in accordance with the latest package insert. Study participants with a baseline eGFR of 60 mL/min/1.73m2 or higher will receive 20mg/day of finerenone (equivalent to 20mg/day in the placebo group) as the starting dose.
Study participants will be instructed to take either finerenone or placebo orally once daily (preferably at approximately the same time every during the morning). For study participants with baseline eGFR less than 60mL/min/1.73 m2, the starting dose will be 10mg/day of finerenone (equivalent to 10mg/day in the placebo group), followed by 20 mg/day (equivalent to 20mg/day in the placebo group) approximately 4 weeks after the first dose, in accordance with the latest package insert. The dose should be increased to 20mg/day (equivalent to 20mg/day in the placebo group) in principle after 4 weeks from the start of the first dose, in accordance with the latest package insert. Study participants with a baseline eGFR of 60 mL/min/1.73m2 or higher will receive 20mg/day of finerenone (equivalent to 20mg/day in the placebo group) as the starting dose.
Saga University Hospital
Saga, Japan
Change in CAVI
Change in CAVI at 24 weeks after initiation of protocol treatment compared to baseline
Time frame: 24 weeks
Change in UACR
Proportional changes in geometric mean of UACR at 12 and 24 weeks post-protocol treatment compared to baseline (key secondary endpoint)
Time frame: 12 weeks, 24 weeks
Change in pentosidine
Proportional changes in geometric mean of pentosidine at 24 weeks post-protocol treatment compared to baseline
Time frame: 24 weeks
Change in urinary type IV collagen
Proportional changes in geometric mean of urinary type IV collagen at 24 weeks post-protocol treatment compared to baseline
Time frame: 24 weeks
Change in urinary alpha1-MG
Proportional changes in geometric mean of urinary alpha1-MG at 24 weeks post-protocol treatment compared to baseline
Time frame: 24 weeks
Change in urinary beta2-MG
Proportional changes in geometric mean of urinary beta2-MG at 24 weeks post-protocol treatment compared to baseline
Time frame: 24 weeks
Change in urinary NGAL
Proportional changes in geometric mean of urinary NGAL at 24 weeks post-protocol treatment compared to baseline
Time frame: 24 weeks
Change in urinary NAG
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Proportional changes in geometric mean of urinary NAG at 24 weeks post-protocol treatment compared to baseline
Time frame: 24 weeks
Change in urinary L-FABP
Proportional changes in geometric mean of urinary L-FABP at 24 weeks post-protocol treatment compared to baseline
Time frame: 24 weeks