Background
Methods
Trial overview, ethical consideration, and patient recruitment
Study population
Inclusion criteria | Exclusion criteria |
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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) |
Randomization and blinding
Treatment and follow-up
6. If a participant declines to participate in the trial or withdraws his/her consent |
7. If a participant finds it challenging to visit the research institution due to relocation or hospital transfer |
8. If participants did not meet the selection criteria or if they have violated the inclusion/exclusion criteria after the initiation of the study |
9. If a participant is unable to continue the research due to the development of an adverse event according to the investigator’s discretion |
10. If the investigator finds it challenging to continue the research due to worsening of the primary disease or complications |
11. If the blind code is opened 12. If the investigator finds that it is appropriate to discontinue participation in the trial due to certain reasons |