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NOT YET RECRUITING
NCT07667517
PHASE4

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

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Finerenone for the Early Regression of Albuminuria in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2026-07-01

Completion Date

2027-12-31

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

DRUG

Finerenone (BAY 94-8862)

Oral finerenone 10 mg or 20 mg once daily, with dose titration by serum potassium and eGFR, for 180 days.

DRUG

Placebo

Matching placebo tablets, identical in appearance to finerenone, orally once daily, following the same dosing and titration schedule, for 180 days.

Locations (13)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

Sanshui Hospital, Zhujiang Hospital, Southern Medical University

Foshan, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Nantong First People's Hospital

Nantong, Jiangsu, China

The First People's Hospital of Suqian

Suqian, Jiangsu, China

Suzhou Science and Technology City Hospital

Suzhou, Jiangsu, China

Xi'an Daxing Hospital

Xi'an, Shaanxi, China

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China