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

• Status: Not yet recruiting
• Trial end date: 2026-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saga University

Criteria

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

• 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).