Finerenone for Regression of Albuminuria in Type 2 Diabetes With Chronic Kidney Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Finerenone (BAY 94-8862): Oral finerenone 10 mg or 20 mg once daily, with dose titration by serum potassium and eGFR, for 180 days.
Placebo: Matching placebo tablets, identical in appearance to finerenone, orally once daily, following the same dosing and titration schedule, for 180 days.
Study 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.
Eligibility
Primary outcome measure(s)
- Albuminuria regression rate — 180 days
Proportion of participants achieving albuminuria regression, defined as a reduction in UACR KDIGO albuminuria category (A3 to A2 or A1, or A2 to A1) together with a \>=30% reduction in UACR from baseline.
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | |
| Fujian Provincial Hospital | Fuzhou | Fujian | |
| Sanshui Hospital, Zhujiang Hospital, Southern Medical University | Foshan | Guangdong | |
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | |
| Nantong First People's Hospital | Nantong | Jiangsu | |
| The First People's Hospital of Suqian | Suqian | Jiangsu | |
| Suzhou Science and Technology City Hospital | Suzhou | Jiangsu | |
| Xi'an Daxing Hospital | Xi'an | Shaanxi | |
| Shanghai Municipal Hospital of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | |
| The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
More First Affiliated Hospital of Zhejiang University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07667517 on ClinicalTrials.gov ↗ ← All trials in China