Effect of Low-Dose Spironolactone and Finerenone on Urinary Albumin Excretion in Patients with Type2 Diabetes

JRCT ID: jRCTs031240068

Registered date:09/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 09/05/2024
• Target sample size: 260
• Study type: Interventional
• Intervention(s): Spironolactone, Finerenone

Outcome(s)

• Primary Outcome: Geometric mean change from baseline in UACR after 26 weeks of drug administration

Secondary Outcome

(1) Geometric mean change from baseline in UACR after 12 weeks of drug administration
(2) Change from baseline in urinary albumin/creatinine ratio after 12, 26 weeks
(3) Change from baseline in systolic and diastolic blood pressure after 12, 26 weeks of treatment with study drug
(4) Percentage transition of albuminuria class

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria
(1) Patients with type 2 diabetes
(2) Patients who are 20 years of age or older at the time of consent
(3) Patients with an eGFR of 30 or greater (mL/min/1.73m2) on examination within 13 weeks prior to obtaining consent
(4) UACR (urinary albumin to creatinine ratio) greater than or equal to 30 and less than 5000 (mg/gCr) within 13 weeks prior to obtaining consent
(5) Patients taking RAS inhibitors and SGLT-2 inhibitors for at least 180 days prior to obtaining consent
(6) Patients who have not been taking MR antagonists including spironolactone and finelenone for at least 90 days prior to obtaining consent
(7) Patients who have given a full explanation of their participation in this study and have given written consent of their own free will.

Exclude criteria

Exclude any of the following
(1) Patients with a history of hyperkalemia (serum potassium level > 5.0 mEq/L) within 180 days prior to obtaining consent
(2) Patients with allergy to MRAs including spironolactone and finelenone
(3) Pregnant or lactating female patients
(4) Other patients deemed inappropriate as subjects by the investigator.

Related Information

• Primary Sponsor: Takayama Shohei