drugset / Trial / NCT07667517

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

Phase 4 Not yet recruiting 148 enrolled First Affiliated Hospital of Zhejiang University

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2026-07-01
Primary completion: 2027-10-31
Completion: 2027-12-31

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Finerenone	Small molecule	10 mg	Oral
Subject	Finerenone	Small molecule	20 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications