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

June 19, 2026 updated by: Xiaomu Li, First Affiliated Hospital of Zhejiang University

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and rationale: Finerenone is an oral, highly selective nonsteroidal mineralocorticoid receptor antagonist approved in China for the treatment of chronic kidney disease associated with type 2 diabetes (with albuminuria). In the phase III FIDELIO-DKD and FIGARO-DKD trials, finerenone added to a maximum tolerated dose of a renin-angiotensin system inhibitor significantly and durably reduced the urine albumin-to-creatinine ratio (UACR) and lowered the risk of kidney and cardiovascular events, with a manageable hyperkalemia risk. A meaningful reduction in albuminuria is an established early surrogate for slowing CKD progression and reducing cardiovascular risk. This study evaluates whether finerenone can achieve early regression of albuminuria in patients with type 2 diabetes and CKD.

Design: This is a multicenter, randomized, double-blind, placebo-controlled trial conducted at up to 12 sites in China. A planned 148 participants are allocated 1:1 to finerenone or matching placebo using central, block randomization (interactive response technology), stratified by baseline UACR (<300 vs >=300 mg/g). Participants and investigators are blinded; placebo tablets are identical in appearance to finerenone, and intervention-period UACR samples are assayed centrally after study completion to preserve blinding.

Population: Eligible participants are adults with type 2 diabetes and CKD (eGFR >= 30 mL/min/1.73 m^2 and UACR 30-2000 mg/g) who have received a maximum tolerated dose of an ACE inhibitor or ARB for at least 90 days and have serum potassium <= 5.0 mmol/L.

Intervention and dose titration: The starting dose is determined by screening eGFR: 10 mg once daily for 30 <= eGFR < 60 mL/min/1.73 m^2, or 20 mg once daily for eGFR >= 60 mL/min/1.73 m^2. The dose is up-titrated to 20 mg, maintained, interrupted, or down-titrated to 10 mg based on serum potassium and eGFR at scheduled and, if needed, unscheduled safety visits. Treatment continues for 180 days.

Visit schedule: a screening period (Day -30 to -1; V1); a treatment period ; and an off-treatment follow-up at Day 210 +/- 5 (V7). Unscheduled safety visits and early-discontinuation visits are performed as needed.

Endpoints: The primary endpoint is the albuminuria regression rate at 180 days, 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. Secondary endpoints include the change in UACR, the rate of regression to normoalbuminuria, the proportions achieving >=30/40/50% UACR reduction, KDIGO GFR-Albuminuria category improvement, the change in UACR 30 days after discontinuation, the change in eGFR slope, and the change in blood pressure. Safety endpoints include adverse events, serious adverse events, and adverse events of special interest (notably serum potassium changes and hyperkalemia). Exploratory endpoints also included.

Study Type

Interventional

Enrollment (Estimated)

148

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Zhihong Wang
          • Phone Number: +8613883021919
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Provincial Hospital
        • Contact:
          • Junping Wen
          • Phone Number: +8613559925729
    • Guangdong
      • Foshan, Guangdong, China
        • Sanshui Hospital, Zhujiang Hospital, Southern Medical University
        • Contact:
          • Zhen Zhang
          • Phone Number: +8615913162742
      • Guangzhou, Guangdong, China
        • Nanfang Hospital, Southern Medical University
        • Contact:
          • Junyu Xue
          • Phone Number: +8618613166333
    • Jiangsu
      • Nantong, Jiangsu, China
        • NanTong First People's Hospital
        • Contact:
          • Xueqin Wang
          • Phone Number: +8613813609566
      • Suqian, Jiangsu, China
        • The First People's Hospital of Suqian
        • Contact:
          • Hong Zhu
          • Phone Number: +8618012186759
      • Suzhou, Jiangsu, China
        • Suzhou Science and Technology City Hospital
        • Contact:
          • Zhimin Ma
          • Phone Number: +8617715187073
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Xi'an Daxing Hospital
        • Contact:
          • Ying Xing
          • Phone Number: +8613991955717
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Zhongshan Hospital, Fudan University
        • Contact:
          • Yuejuan Liu
          • Phone Number: +8613472844268
      • Shanghai, Shanghai Municipality, China
        • Shanghai Municipal Hospital of Traditional Chinese Medicine
        • Contact:
          • Feng Tao
          • Phone Number: +8613818808324
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
      • Ningbo, Zhejiang, China
        • The First Affiliated Hospital of Ningbo University
        • Contact:
          • Li Li
          • Phone Number: +8613757426626
      • Wenzhou, Zhejiang, China
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Hong Zhu
          • Phone Number: +8613758712421

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 m^2, and UACR 30-2000 mg/g (mean of 3 measurements).
  • 4. Serum potassium <= 5.0 mmol/L.
  • 5. On a maximum tolerated dose of an ACE inhibitor or ARB for at least 90 days.
  • 6. Treatment with an SGLT-2 inhibitor, GLP-1 receptor agonist, or other agents affecting UACR is permitted, but the type and dose must be stable for at least 30 days before screening.

Exclusion Criteria:

  • 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.
  • 5. Hepatic impairment (Child-Pugh class C).
  • 6. Blood pressure > 160/100 mmHg, or systolic blood pressure < 90 mmHg, at the screening visit.
  • 7. Bilateral renal artery stenosis.
  • 8. Known hypersensitivity to the study drug (active substance or excipients).
  • 9. Treatment with finerenone within 60 days before screening.
  • 10. Stroke, transient ischemic attack, acute coronary syndrome (myocardial infarction, CABG, PCI), or hospitalization for worsening heart failure within 90 days before the screening visit.
  • 11. NYHA class II-IV heart failure.
  • 12. Addison's disease.
  • 13. Gastrointestinal surgery that may affect drug absorption.
  • 14. Any other history, condition, therapy, or uncontrolled concomitant disease that makes the participant unsuitable for the study or unlikely to complete it (e.g., active malignancy or other disease with life expectancy < 12 months).
  • 15. Treatment with a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin, nefazodone), a strong CYP3A4 inducer (e.g., carbamazepine, phenytoin, phenobarbital, St. John's wort), or a moderate CYP3A4 inducer (e.g., efavirenz) that cannot be discontinued for at least 7 days before randomization.
  • 16. Treatment with another mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone, esaxerenone) or a potassium-sparing diuretic (e.g., amiloride, triamterene) that cannot be discontinued for at least 60 days before the screening visit.
  • 17. Biopsy-confirmed non-diabetic kidney disease (e.g., IgA nephropathy).
  • 18. Immunosuppressive therapy, or glucocorticoid use by any route other than topical or inhaled, within the past 180 days.
  • 19. Participation in another interventional clinical study or use of any investigational product within 90 days before randomization.
  • 20. History of alcohol or drug abuse.
  • 21. Women of childbearing potential who are pregnant, breastfeeding, intend to become pregnant, or are not using adequate contraception during the study.
  • 22. Any other condition deemed by the investigator to make the participant unsuitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Finerenone
Finerenone film-coated tablets, orally once daily, on top of standard background therapy. Starting dose determined by screening eGFR: 10 mg if 30 <= eGFR < 60 mL/min/1.73 m^2, or 20 mg if eGFR >= 60 mL/min/1.73 m^2. Dose up-titrated to 20 mg, maintained, interrupted, or down-titrated to 10 mg based on serum potassium and eGFR. Treatment duration 180 days.
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.
Placebo Comparator: Placebo
Matching placebo tablets identical in appearance to finerenone, orally once daily, on top of standard background therapy, following the same dosing and titration schedule. Treatment duration 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Albuminuria regression rate
Time Frame: 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.
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio
Time Frame: Baseline and 180 days
Urinary albumin-to-creatinine ratio will be measured in mg/g. Percent change from baseline will be calculated as: (Day 180 UACR - baseline UACR) / baseline UACR × 100%.
Baseline and 180 days
Percentage of Participants With Normoalbuminuria
Time Frame: 180 days
Normoalbuminuria is defined as urinary albumin-to-creatinine ratio less than 30 mg/g at Day 180.
180 days
Percentage of Participants by UACR Reduction Response Category at Day 180
Time Frame: Baseline to Day 180
Percent reduction in urinary albumin-to-creatinine ratio (UACR) from baseline to Day 180 will be calculated for each participant. Participants will be classified into one of four mutually exclusive UACR reduction response categories: no more than 30% reduction, more than 30% to no more than 40% reduction, more than 40% to no more than 50% reduction, and more than 50% reduction. Participants with no reduction or an increase in UACR will be included in the no more than 30% reduction category. The outcome will be reported as the percentage of participants in each response category.
Baseline to Day 180
Percentage of Participants With Improvement in Kidney Disease: Improving Global Outcomes Albuminuria Category at Day 180
Time Frame: Baseline to Day 180
Improvement in albuminuria category is defined as a change from A3 to A2 or A1, or from A2 to A1, according to Kidney Disease: Improving Global Outcomes urinary albumin-to-creatinine ratio categories.
Baseline to Day 180
Change From Day 180 to Day 210 in Urinary Albumin-to-Creatinine Ratio
Time Frame: Day 180 to Day 210
Change in urinary albumin-to-creatinine ratio from Day 180 to Day 210 will be assessed in mg/g, corresponding to the 30-day off-treatment follow-up period.
Day 180 to Day 210
Estimated Glomerular Filtration Rate Slope Through Day 180
Time Frame: Baseline through Day 180
Estimated glomerular filtration rate will be calculated using the CKD-EPI equation. The eGFR slope through Day 180 will be estimated from serial eGFR measurements and reported in mL/min/1.73 m2 per year.
Baseline through Day 180
Change From Baseline in Systolic Blood Pressure at Day 180
Time Frame: Baseline to Day 180
Change in systolic blood pressure from baseline to Day 180 will be assessed in mmHg.
Baseline to Day 180
Change From Baseline in Diastolic Blood Pressure at Day 180
Time Frame: Baseline to Day 180
Change in diastolic blood pressure from baseline to Day 180 will be assessed in mmHg.
Baseline to Day 180

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events
Time Frame: From first dose through Day 210
The outcome will be reported as the percentage of participants experiencing at least one adverse event from first dose through the end of the 30-day off-treatment follow-up period.
From first dose through Day 210
Percentage of Participants With Serious Adverse Events
Time Frame: From first dose through Day 210
The outcome will be reported as the percentage of participants experiencing at least one serious adverse event from first dose through the end of the 30-day off-treatment follow-up period.
From first dose through Day 210
Adverse events of special interest (AESI)
Time Frame: Up to 210 days
Including change in serum potassium and incidence of hyperkalemia, incidence of eGFR decline >30% at Day 30, reversibility of eGFR after discontinuation, acute kidney injury, urogenital infection, severe hypoglycemia, symptomatic hypotension, and ketoacidosis
Up to 210 days
Change in Composite MRI-PDFF-derived Peri-organ Visceral Fat Fraction
Time Frame: Baseline and 180 days
Abdominal magnetic resonance imaging proton density fat fraction will be used to quantify visceral fat fraction (%) in prespecified perirenal, peripancreatic, and perihepatic regions of interest. A composite peri-organ visceral fat fraction will be calculated for each participant as the arithmetic mean of the region-specific MRI-PDFF values from the perirenal, peripancreatic, and perihepatic regions. The outcome will be reported as the percentage-point change in the composite peri-organ visceral fat fraction from baseline to Day 180.
Baseline and 180 days
Change in Urine Metabolomic Composite Score
Time Frame: Baseline to Day 180
Urine metabolomic features will be measured using a prespecified metabolomics platform. Normalized metabolite feature intensities will be standardized, and a urine metabolomic composite score will be calculated according to the statistical analysis plan. The outcome will be reported as change in composite score from baseline to Day 180.
Baseline to Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 14, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2026C]IIT No.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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