Evaluating the effects of finerenone on kidney function in patients with Type 2 diabetes and chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the impact of finerenone on renal function and diabetic complications in patients diagnosed with Type 2 diabetes and chronic kidney disease. It is a prospective, single-arm, multicenter clinical trial involving 300 participants who will receive finerenone added to their existing treatment regimen for 48 weeks. The primary endpoint is the change in urine albumin-to-creatinine ratio, while secondary endpoints include various markers of renal and cardiovascular health. Safety assessments will also be conducted throughout the study period.

Why it matters

Who can join: the full rules

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

Where it's running

• The Second Affiliated Hospital of Suzhou University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Xie Ying, Ph.D. — Second Affiliated Hospital of Suzhou University
• Study coordinator: Xie Ying, Ph.D.
• Email: 13013883877@126.com
• Phone: 13962187062

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Finerenone in adults with CKD and type 2 diabetes in Spain: real-world changes in kidney risk score

  This observational study tests how finerenone affects a kidney-risk score in adults with CKD linked to type 2 diabetes who are already taking finerenone in routine care in Spain.

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• Observational study on the use of finerenone for chronic kidney disease and type 2 diabetes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.