臨床研究等提出・公開システム

Exploratory, non-blinded, single-arm study of finerenone for primary aldosteronism

Finerenone study for PA

Wada Jun

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama

junwada@okayama-u.ac.jp

Fujisawa Satoshi

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama

+81-86-235-7234

fujisawa_sa@okayama-u.ac.jp

Recruiting

July. 15, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Patients aged 18 to 80 years old
2) Patients who provide written consent to participate in this study
3) Patients diagnosed with primary aldosteronism based on the results of at least one of the following tests: captopril challenge test or saline loading test

1) Pregnant women
2) Breastfeeding women
3) Patients with severe renal dysfunction (eGFR: less than 25 mL/min/1.73m2)
4) Patients undergoing renal replacement therapy (hemodialysis or peritoneal dialysis)
5) Patients who have previously undergone renal transplantation
6) Patients with severe hepatic impairment (Child-Pugh classification B or C)
7) Patients with hyperkalemia (K > 5.5 mEq/L)
8) Patients with Addison's disease
9) Patients with a history of hypersensitivity to finerenone ingredients
10) Patients who have taken spironolactone, eplerenone, or esaxerenone within 8 weeks before enrollment
11) Patients taking drugs listed as contraindications for concomitant use for finerenone
12) Patients judged by the principal investigator or subinvestigator to be ineligible for the study.

Both

Primary aldosteronism

once a day finerenone orally administered for 12 weeks

Plasma renin activity after 4 and 12 weeks

1) Active renin concentration after 4 and 12 weeks
2) Serum potassium level after 4 and 12 weeks
3) Proteinuria after 4 and 12 weeks
4) Albuminuria after 4 and 12 weeks
5) eGFR after 4 and 12 weeks
6) Clinic blood pressure after 4 and 12 weeks
7) Home blood pressure after 4 and 12 weeks
8) Incidence of hyperkalemia for 12 weeks
9) Incidence of doubling of serum creatinine for 12 weeks
10) Incidence of other adverse events for 12 weeks

+81-86-235-6503

June. 24, 2025

No

none