Type 2 Diabetes Mellitus, Chronic Kidney Disease
Conditions
Interventions
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 medi
Sponsors
Inagaki Nobuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in UACR from baseline (week 0) to week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactNobuya Inagaki
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofukai
Outcome results
None listed