NIPH Clinical Trials Search

Evaluate the Key practicalitY of dOse up-titraTion and biOmarker of FINErenone in patients with CKD and T2D

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Type 2 Diabetes Mellitus, Chronic Kidney Disease
Date of first enrollment	24/04/2026
Target sample size	250
Countries of recruitment
Study type	Interventional
Intervention(s)	After the tests at baseline (week 0), itiniate administration of finerenone 10 mg/day or 20 mg/day, based on JSN eGFRcr, serum potassium, and judgement of investigator/subinvestigators from other medical conditions of patients. Thereafter, up/down-titration, discontinuation, or re-administration of finerenone are allowed, based on JSN eGFRcr, serum potassium, and judgement of investigator/subinvestigators from other medical conditions of patients.

Outcome(s)

Primary Outcome	Change in UACR from baseline (week 0) to week 24
Secondary Outcome	1. Proportion of patients who receive finerenone 20 mg at week 4, 8, 12, or 24 among the patients who initiated finerenone 10 mg at baseline (week 0) 2. Change in UACR from baseline (week 0) to week 4, 12, or 24 in patients who initiated finerenone 10 mg at baseline and receive 20 mg at the observation point

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients who meet all of the following criteria are included in this study; 1. Males and females aged 18 years or older at giving their consent 2. Patients diagnosed with type 2 diabetes mellitus based on the diagnostic criteria of the Japanese Clinical Practice Guideline for Diabetes 2024 issued by the Japan Diabetes Society 3. Patients with chronic kidney disease who meet both of the following criteria at latest and within 4 weeks prior to consenting - 25 =< JSN eGFRcr < 60 mL/min/1.73m2 - 30 =< UACR =< 5,000 mg/g Cre 4. Patients who provide written consent to participate in this study by themselves or through legal representatives after receiving a thorough explanation of this study
Exclude criteria	Patients who meet any of the following criteria are excluded from this study; 1. Patients with HbA1c >= 10% at latest and within 4 weeks prior to consenting 2. Patients with significant non-diabetic renal diseases (including clinically significant renal artery stenosis) 3. Patients with JSN eGFRcr < 20 mL/min/1.73m2 at latest and within 4 weeks prior to consenting 4. Patients with serum or plasma potassium > 5.0 mmol/L at latest and within 4 weeks prior to consenting 5. Patients who cannot receive oral administration of medical agents 6. Patients who used eplerenone, spironolactone, or esaxerenone within 30 days prior to consenting. 7. Patients with poorly controlled arterial hypertension (mean systolic blood pressure >= 170 mmHg or mean diastolic blood pressure >= 110 mmg 8. Patients with history of stroke, transient brain ischemia, or acute coronary syndrome, or history of hospitalization due to worsening of heart failure within 30 days prior to consenting 9. Patients who are contraindicated by the package insert of finerenone in Japan (as following); - Patients with a hystory of hypersensitivity to any component of this drug - Patients receiving itraconazole, posaconazole, voriconazole, ritonavir-containing formulations, atazanavir, darunavir, fosamprenavir, cobicistat-containing formulations, clarithromycin, or ensitrelvir - Patients with severe hepatic impairment (Child-Pugh class C) - Patients with Addison's disease 10. Patients who are pregnant, breastfeeding or may be pregnant; patients who wish to become pregnant between the time of consenting to the end of this study; or patients who cannot be persuaded for contraception 11. Patients with other conditions, who are judged to be unsuitable for participation in this study by investigator/subinvestigators