About this trial

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 criteria

Qualifiers

1. Age >= 18 years at the time of signing informed consent, male or female.

2. Type 2 diabetes mellitus.

3. Chronic kidney disease meeting BOTH of the following: eGFR (CKD-EPI) >= 30 mL/min/1.73 m², and UACR 30-2000 mg/g (mean of 3 measurements).

4. Serum potassium <= 5.0 mmol/L.

Disqualifiers

1. Type 1 diabetes, other specific types of diabetes, or gestational diabetes.

2. HbA1c >= 8.0%.

3. On renal replacement therapy.

4. Acute kidney injury within 180 days before the screening visit.

Trial design

Treatments tested in this trial

  • Finerenone (BAY 94-8862)
  • Placebo

Treatment groups

148 Participants
are divided into 2 treatment groups

Locations

13
The First Affiliated Hospital of Chongqing Medical University ChongqingChongqing Municipality, China
Fujian Provincial Hospital FuzhouFujian, China
Sanshui Hospital, Zhujiang Hospital, Southern Medical University FoshanGuangdong, China
Nanfang Hospital, Southern Medical University GuangzhouGuangdong, China

Sponsors and collaborators

First Affiliated Hospital of Zhejiang University

Lead sponsor