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Clinical Trials in China / NCT06838416
Recruiting Observational

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

NCT06838416 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital of Soochow University
Phase
Observational
Started
2023-11-17
Last updated
2025-04-04

Condition(s) studied

Type 2 Diabetes MellitusChronic Kidney DiseaseRenal Function

Investigational drug(s) / intervention(s)

Finerenone →

Finerenone: Treatment will continue for 48 weeks.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Suzhou University Suzhou Jiangsu Recruiting

More Second Affiliated Hospital of Soochow University trials in China

Other trials for the same condition

Official registry record

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 NCT06838416 on ClinicalTrials.gov ↗ ← All trials in China