臨床研究等提出・公開システム

Exploratory study on the safety and efficacy of oral finerenone for renal function impairment after renal surgery

FARS Trial

Kakutani Shigenori

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

kakushigean@yahoo.co.jp

Kakutani Shigenori

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku,Tokyo

+81-3-3815-5411

kakushigean@yahoo.co.jp

Recruiting

Jan. 23, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Patients who have undergone kidney surgery
(2) Patients with diabetes mellitus who have an HbA1c >= 6.5% or are being treated with antidiabetic medication within 1 year prior to obtaining consent.
(3) Patients with Chronic Kidney Disease (CKD).
(4) Age: 18 years or older and less than 85 years at the time of obtaining consent.
(5) Sex: Any.
(6) Patients who have given written informed consent of their own free will after receiving a full explanation regarding participation in this study and fully understanding the contents.
(7) Patients who are able to visit the outpatient clinic according to the study schedule

(1) Patients requiring treatment with anticancer drugs or similar agents.
(2) Patients with active renal or systemic inflammation.
(3) Patients with an eGFR < 25 mL/min/1.73 m2.
(4) Patients with a history of allergy to finerenone.
(5) Patients currently receiving medications containing itraconazole, posaconazole, voriconazole, or ritonavir; medications containing atazanavir, darunavir, fosamprenavir, or cobicistat; clarithromycin; or ensitrelvir.
(6) Patients with a serum potassium level > 4.8 mEq/L at the time of enrollment.
(7) Patients with severe hepatic impairment (Child-Pugh Class C).
(8) Patients with Addison's disease.
(9) Patients who are pregnant or possibly pregnant.
(10) Patients who are breastfeeding.
(11) Any other patients deemed ineligible for participation in this study by the Principal Investigator or Co-Investigator

Both

Diabetic patients who have undergone kidney-related surgery

Administration of finerenone for 6 months to diabetic patients after kidney surgery.

Diabetic patients who have undergone kidney-related surgery

finerenone

Incidence of adverse events for which a causal relationship with the investigational drug cannot be ruled out

(1) Degree of improvement in renal function at 24 weeks after administration.
(2) Degree of improvement in proteinuria at 24 weeks after administration.
(3) Renal ultrasonography assessment at 24 weeks after administration.
(4) Incidence of all adverse events

+81-3-5841-3600

Dec. 29, 2025

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