Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)

Saga University

Status and phase: Active, not recruiting; Phase 4

Conditions: Chronic Kidney Diseases; Type 2 Diabetes

Treatments: Drug: Finerenone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05887817

00002

Details and patient eligibility

About

To evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in patients with type 2 diabetes and chronic kidney disease.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Finerenone

Experimental group

Description:

Kerendia® tablets

Treatment:

Drug: Finerenone

Placebo

Placebo Comparator group

Description:

Placebo tablets

Treatment:

Drug: Placebo