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

NCT07667517 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: [2026C]IIT No.001
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Albuminuria; Type 2 Diabetes Mellitus (T2DM); Chronic Kidney Diseases

Keywords

Finerenone; Nonsteroidal mineralocorticoid receptor antagonist; Urine albumin-to-creatinine ratio; KDIGO; Albuminuria regression

Outcome Measures

Primary Outcomes (1)

• Albuminuria regression rate

  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 Outcomes (8)

• Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio

  Baseline and 180 days

• Percentage of Participants With Normoalbuminuria

  180 days

• Percentage of Participants by UACR Reduction Response Category at Day 180

  Baseline to Day 180

• Percentage of Participants With Improvement in Kidney Disease: Improving Global Outcomes Albuminuria Category at Day 180

  Baseline to Day 180

• Change From Day 180 to Day 210 in Urinary Albumin-to-Creatinine Ratio

  Day 180 to Day 210

Other Outcomes (5)

• Percentage of Participants With Adverse Events

  From first dose through Day 210

• Percentage of Participants With Serious Adverse Events

  From first dose through Day 210

• Adverse events of special interest (AESI)

  Up to 210 days

Study Arms (2)

Finerenone

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

Finerenone (BAY 94-8862) DRUG

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

Finerenone

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age \>= 18 years at the time of signing informed consent, male or female.
• \. Type 2 diabetes mellitus.
• \. 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).
• \. Serum potassium \<= 5.0 mmol/L.
• \. On a maximum tolerated dose of an ACE inhibitor or ARB for at least 90 days.
• \. 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.

You may not qualify if:

• \. Type 1 diabetes, other specific types of diabetes, or gestational diabetes.
• \. HbA1c \>= 8.0%.
• \. On renal replacement therapy.
• \. Acute kidney injury within 180 days before the screening visit.
• \. Hepatic impairment (Child-Pugh class C).
• \. Blood pressure \> 160/100 mmHg, or systolic blood pressure \< 90 mmHg, at the screening visit.
• \. Bilateral renal artery stenosis.
• \. Known hypersensitivity to the study drug (active substance or excipients).
• \. Treatment with finerenone within 60 days before screening.
• \. Stroke, transient ischemic attack, acute coronary syndrome (myocardial infarction, CABG, PCI), or hospitalization for worsening heart failure within 90 days before the screening visit.
• \. NYHA class II-IV heart failure.
• \. Addison's disease.
• \. Gastrointestinal surgery that may affect drug absorption.
• \. 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).
• \. 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (13)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Fujian Provincial Hospital

Fuzhou, Fujian, China

Location

Sanshui Hospital, Zhujiang Hospital, Southern Medical University

Foshan, Guangdong, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

Nantong First People's Hospital

Nantong, Jiangsu, China

Location

The First People's Hospital of Suqian

Suqian, Jiangsu, China

Location

Suzhou Science and Technology City Hospital

Suzhou, Jiangsu, China

Location

Xi'an Daxing Hospital

Xi'an, Shaanxi, China

Location

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

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  PMID: 24191305 BACKGROUND

• Coresh J, Grams ME, Chen TK. Using GFR, Albuminuria, and Their Changes in Clinical Trials and Clinical Care. Am J Kidney Dis. 2021 Sep;78(3):333-334. doi: 10.1053/j.ajkd.2021.04.003. Epub 2021 May 28. No abstract available.

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• Marup FH, Thomsen MB, Birn H. Additive effects of dapagliflozin and finerenone on albuminuria in non-diabetic CKD: an open-label randomized clinical trial. Clin Kidney J. 2023 Sep 26;17(1):sfad249. doi: 10.1093/ckj/sfad249. eCollection 2024 Jan.

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  RESULT

MeSH Terms

Conditions

Albuminuria; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

finerenone

Condition Hierarchy (Ancestors)

Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Central Study Contacts

Yuejun Liu

CONTACT

+8613472844268; yuejunliu7@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Endocrinology

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)