Clinical Trial

Finerenone for Regression of Albuminuria in Type 2 Diabetes With Chronic Kidney Disease

Not Yet Recruiting Phase 4
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Summary
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, for the early regression of albuminuria in adults with type 2 diabetes mellitus and chronic kidney disease (eGFR \>= 30 mL/min/1.73 m\^2 and UACR 30-2000 mg/g) who are already receiving a maximum tolerated dose of an ACE inhibitor or ARB. A total of 148 participants are randomized 1:1, stratified by baseline UACR (\<300 vs \>=300 mg/g), to oral finerenone (10 or 20 mg once daily, titrated by serum potassium and eGFR) or matching placebo, on top of standard background therapy, for 180 days, followed by a 30-day off-treatment follow-up. Albuminuria regression is defined as both an improvement in Kidney Disease: Improving Global Outcomes albuminuria category, from A3 to A2 or A1, or from A2 to A1, and a more than 30% reduction in urinary albumin-to-creatinine ratio from baseline. The outcome will be reported as the percentage of participants meeting this definition at Day 180.
Trial Details
NCT Number NCT07667517
Lead Sponsor First Affiliated Hospital of Zhejiang University
Conditions Albuminuria, Type 2 Diabetes Mellitus (T2DM), Chronic Kidney Diseases
Enrollment 148 participants
Start Date 2026-07-01
Primary Completion 2027-10-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-25