Skip to main content

Table 1 Inclusion and exclusion criteria

From: Rationale and design of an investigator-initiated, multicenter, prospective, placebo-controlled, double-blind, randomized trial to evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in type 2 diabetes and chronic kidney disease (FIVE-STAR)

Inclusion criteria

Exclusion criteria

1. Patients who provided a written informed consent

2. Patients who are aged ≥ 20 years at the time of consent (regardless of sex)

3. Patients with T2D

4. Patients with chronic kidney disease who meet the following criteria:

i) eGFR ≥ 25 mL/min/1.73 m2 and < 90 mL/min/1.73 m2

ii) UACR ≥ 30 mg/g Cr and < 3500 mg/g Cr

5. Patients who did not change their medications for T2D and CKD within the last 4 weeks prior to obtaining consent

1. Patients who are currently taking or have taken MRAs containing finerenone within the last 4 weeks prior to obtaining consent

2. Patients with a history of finerenone hypersensitivity

3. Patients with an HbA1c level of > 10%

4. Patients with a serum potassium level of ≥ 4.9 mEq/L

5. Patients with NYHA class II–IV HFrEF (LVEF ≤ 35%)

6. Patients with poorly controlled hypertension (e.g., systolic BP ≥ 170 mmHg, diastolic BP ≥ 110 mmHg, or hypertensive emergencies)

7. Patients with a history of ischemic stroke, acute coronary syndrome, cardiovascular surgery or percutaneous intervention, or hospitalization for worsening heart or renal failure within the last 8 weeks prior to obtaining consent

8. Patients with a preplanned surgical or percutaneous intervention for coronary artery reconstruction or other cardiovascular diseases during the individual observation period

9. Patients with a preplanned treatment such as electrical cardioversion, cardiac resynchronization therapy, and pacemaker implantation during the individual observation period

10. Patients with preplanned dialysis or kidney transplantation during the individual observation period

11. Patients with severe hepatic dysfunction (Child–Pugh class C)

12. Patients receiving itraconazole, ritonavir-containing products, atazanavir, darunavir, fosamprenavir, cobicistat-containing products, or clarithromycin

13. Patients with Addison’s disease

14. Patients with active infectious diseases

15. Pregnant, possibly pregnant, or lactating patients

16. Other patients deemed inappropriate for this study by the investigators (e.g., those with renal artery stenosis, one kidney, or active malignancy)

  1. BP, blood pressure; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; HFrEF, heart failure with reduced ejection fraction; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist; NYHA, New York Heart Association; T2D, type 2 diabetes; UACR, urinary albumin-to-creatinine ratio