Evaluating the effects of finerenone on kidney function in patients with Type 2 diabetes and chronic kidney disease
Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease: A Prospective, Single-Arm, Multicenter Clinical Study
This study is testing if adding a new kidney medication called finerenone can help people with Type 2 diabetes and chronic kidney disease improve their kidney function over 48 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Soochow University Academic / other |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06838416 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Type 2 diabetes and chronic kidney disease who meet specific renal function criteria.
Not a fit: Patients with chronic kidney disease diagnosed before Type 2 diabetes or those with poorly controlled blood pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney function and reduced complications for patients with Type 2 diabetes and chronic kidney disease.
How similar studies have performed: Other studies have shown promise in using finerenone for similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Suzhou, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.