Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease

NCT06838416 | Recruiting DMC FDA Drug

• 2 other identifiers: LK202309400000000202109300008
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Research Objectives To evaluate the impact of finerenone on renal function, diabetic complications, and safety in patients with Type 2 diabetes and chronic kidney disease. Study Design Type: Prospective, single-arm, multicenter clinical trial. Sample Size: 300 patients. Intervention: Finerenone added to existing treatment regimen (10-20 mg once daily, dose adjusted based on eGFR), for 48 weeks. Data Collection Time Points: Baseline, 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks. Primary Endpoint: Change in urine albumin-to-creatinine ratio (UACR). Secondary Endpoints: Changes in eGFR, 24-hour urine protein, serum uric acid, retinopathy markers, pulse wave velocity (PWV), ankle-brachial index (ABI), etc. Safety Endpoints: Changes in serum potassium, sodium, and blood pressure.

Conditions

Type 2 Diabetes Mellitus; Chronic Kidney Disease; Renal Function

Outcome Measures

Primary Outcomes (1)

• Change in Urine Albumin-to-Creatinine Ratio (UACR)

  The primary outcome measure is the change in Urine Albumin-to-Creatinine Ratio (UACR) from baseline to the end of the 48-week treatment period. UACR is a key indicator of renal function and will be assessed to evaluate the efficacy of finerenone in reducing proteinuria in patients with Type 2 diabetes and chronic kidney disease.

  Baseline to Week 48

Secondary Outcomes (6)

• Change in eGFR

  Baseline to Week 48

• Change in 24-Hour Urine Protein Quantification

  Baseline to Week 48

• Change in Blood Uric Acid Levels

  Baseline to Week 48

• Change in Pulse Wave Velocity (PWV)

  Baseline to Week 48

• Change in Ankle-Brachial Index (ABI)

  Baseline to Week 48

Study Arms (1)

Finerenone Treatment Group

All enrolled participants will receive finerenone as an add-on to their existing stable treatment regimen. The dose of finerenone will be adjusted based on eGFR levels at enrollment (10 mg once daily if eGFR \< 60 mL/min/1.73 m²; 20 mg once daily if eGFR ≥ 60 mL/min/1.73 m²).

Drug: Finerenone

Interventions

Finerenone DRUG

Treatment will continue for 48 weeks.

Also known as: Angiotensin II Receptor Blockers

Finerenone Treatment Group

Eligibility Criteria

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

Study Population

This study aims to evaluate the effects of finerenone on renal function and diabetic complications in patients with Type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD). The study population consists of adult patients diagnosed with T2DM and CKD who meet specific inclusion and exclusion criteria.

You may qualify if:

• Diagnosed with Type 2 diabetes according to the 1999 WHO criteria
• Aged ≥18 years
• UACR ≥30 mg/g and eGFR ≥30 ml/min/1.73 m² sustained for over 3 months
• Stable ARB/ACEI treatment for ≥4 weeks prior to enrollment
• Willing to sign a written informed consent and comply with the study protocol

You may not qualify if:

• Chronic kidney disease diagnosed before Type 2 diabetes
• Serum potassium \>4.8 mmol/L
• Ineffective blood pressure control at screening (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg, average of three measurements in the supine position)
• HbA1c \>9%
• Acute urinary tract infection or conditions affecting urine tests
• Primary or secondary adrenal insufficiency
• Use of mineralocorticoid receptor antagonists
• Use of medications with clear effects on urine protein and eGFR within 4 weeks (except kininogenase)
• Use of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone, carbamazepine)
• ALT or AST \>2.5 × ULN, total bilirubin (TBIL) \>2 × ULN
• Use of systemic glucocorticoids for more than 7 days within 12 weeks prior to screening, or use of systemic glucocorticoids (intravenous/oral or intra - articular) or need for systemic immunosuppressive treatment within the past 14 days
• Any organ system cancer within the past 5 years, whether treated or untreated
• Known pregnancy (positive pregnancy test), breastfeeding, recent plans for conception, or not using adequate contraception
• Participation in other interventional clinical trials within 3 months prior to screening

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

The Second Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

finerenone; Angiotensin Receptor Antagonists

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Xie Ying, Ph.D.

  Second Affiliated Hospital of Suzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xie Ying, Ph.D.

CONTACT

13962187062; 13013883877@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 20, 2025
• Study Start: November 17, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-02

Locations

CN (1)