Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
- Conditions
- Chronic Kidney DiseasesType 2 Diabetes
- Interventions
- Drug: Placebo
- Registration Number
- NCT05887817
- Lead Sponsor
- Saga University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Patients who have given their written consent to participate in this study
- Patients who are 20 years of age or older at the time of consent (regardless of gender)
- Patients with type 2 diabetes mellitus
- Patients with chronic kidney disease who meet both of the following criteria; i) eGFR greater than 25 mL/min/1.73 m2 and less than 90 mL/min/1.73 m2, ii) UACR greater than 30 mg/g.cr. and less than 3500 mg/g.cr.
- Patients who have not changed their medications for type 2 diabetes and chronic kidney disease in the past 4 weeks prior to obtaining consent
- Patients who are currently taking or have taken MRAs containing finerenone in the past 4 weeks prior to obtaining consent.
- Patients with a history of hypersensitivity to finerenone
- Patients with HbA1c greater than 10%.
- Patients with a serum potassium level of 4.9 mEq/L or higher
- Patients with NYHA class II-IV HFrEF (LVEF <35%)
- Patients with poorly controlled hypertension (e.g., systolic BP >170 mmHg, diastolic BP >110 mmHg, or hypertensive emergencies)
- Patients with a history of ischemic stroke, acute coronary syndrome, cardiovascular surgery or percutaneous intervention, or hospitalization for worsening heart or renal failure in the past 8 weeks prior to obtaining consent
- Patients with a preplanned surgical or percutaneous intervention for coronary artery reconstruction or other cardiovascular disease during the individual observation period.
- Patients with a preplanned treatment such as electrical cardioversion, cardiac resynchronization therapy or pacemaker implantation during the individual observation period.
- Patients with preplanned dialysis or kidney transplantation during the individual observation period.
- Patients with severe hepatic dysfunction (Child-Pugh Class C)
- Patients receiving itraconazole, ritonavir-containing products, atazanavir, darunavir, fosamprenavir, cobicistat-containing products, or clarithromycin, or ensitrelvir
- Patients with Addison's disease
- Patients with active infectious diseases
- Pregnant, possibly pregnant, or lactating patients
- Other patients deemed inappropriate for this study by the principal investigator or subinvestigators (e.g., patients with renal artery stenosis, one kidney, or active malignancy).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo tablets Finerenone Finerenone Kerendia® tablets
- Primary Outcome Measures
Name Time Method Change in CAVI 24 weeks Change in CAVI at 24 weeks after initiation of protocol treatment compared to baseline
- Secondary Outcome Measures
Name Time Method Change in urinary beta2-MG 24 weeks Proportional changes in geometric mean of urinary beta2-MG at 24 weeks post-protocol treatment compared to baseline
Change in urinary NAG 24 weeks Proportional changes in geometric mean of urinary NAG at 24 weeks post-protocol treatment compared to baseline
Change in UACR 12 weeks, 24 weeks Proportional changes in geometric mean of UACR at 12 and 24 weeks post-protocol treatment compared to baseline (key secondary endpoint)
Change in pentosidine 24 weeks Proportional changes in geometric mean of pentosidine at 24 weeks post-protocol treatment compared to baseline
Change in urinary alpha1-MG 24 weeks Proportional changes in geometric mean of urinary alpha1-MG at 24 weeks post-protocol treatment compared to baseline
Change in urinary NGAL 24 weeks Proportional changes in geometric mean of urinary NGAL at 24 weeks post-protocol treatment compared to baseline
Change in urinary type IV collagen 24 weeks Proportional changes in geometric mean of urinary type IV collagen at 24 weeks post-protocol treatment compared to baseline
Change in urinary L-FABP 24 weeks Proportional changes in geometric mean of urinary L-FABP at 24 weeks post-protocol treatment compared to baseline
Trial Locations
- Locations (1)
Saga University Hospital
🇯🇵Saga, Japan