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

ACTIVE NOT RECRUITING

NCT05887817

PHASE4

Sponsor: Saga University

Summary

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

Official title: Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in Type 2 Diabetes and Chronic Kidney Disease (FIVE-STAR)

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-09-07

Completion Date

2026-07-31

Last Updated

2024-02-07

Healthy Volunteers

No

Conditions

Type 2 Diabetes Chronic Kidney Diseases

Interventions

DRUG

Finerenone

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.

DRUG

Placebo

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.

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).

Locations (1)

Saga University Hospital

Saga, Japan

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