Effect of Finerenone on Kidney Inflammation in Non-diabetic Patients
Effect of Finerenone on Proteinuria and GFR Progression in Patients With Non Diabetic Glomerulonephritis: A Randomized Clinical Trial
This study is testing if finerenone can help reduce kidney inflammation and slow down kidney problems in people with non-diabetic kidney disease who have high levels of protein in their urine.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT06835322 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of finerenone, a selective mineralocorticoid receptor antagonist, on reducing proteinuria and slowing the progression of kidney function decline in patients with non-diabetic glomerulonephritis. Participants will receive either finerenone or a placebo while being on maximum tolerated doses of ACE inhibitors or ARBs. The study aims to determine if finerenone can provide better anti-inflammatory and anti-fibrotic effects compared to traditional treatments. The focus is on patients with significant proteinuria and compromised kidney function.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with non-diabetic glomerulonephritis, experiencing high levels of proteinuria and on maximum tolerated doses of ACE inhibitors or ARBs.
Not a fit: Patients with diabetes, other non-glomerular kidney diseases, or uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve kidney health and slow disease progression in patients with non-diabetic glomerulonephritis.
How similar studies have performed: Previous studies have shown that finerenone can effectively reduce proteinuria in chronic kidney disease patients, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. GN patients on maximum tolerated doses of an ACEi or ARBs together with their immunosuppression protocol (if needed) for at least 4 weeks. 2. urinary protein excretion \>500 mg/g. 3. Adult patients with age above 18 years. 4. eGFR ≥ 25 mL/ min/1.73 m2. 5. baseline serum potassium level \<5 mEq/L. Exclusion Criteria: 1. Patients with diabetes mellitus (type 1 or 2). 2. Other non-glomerular kidney diseases. 3. Heart failure. 4. Breast feeding or pregnancy. 5. Patients who received medications to treat hyperkalemia 4 weeks before study. 6. Uncontrolled hypertension (BP \> 160/100).
Where this trial is running
Alexandria
- Faculty of Medicine, Aexandria University — Alexandria, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed Mamdouh Elsayed, MD — Associate professor
- Study coordinator: Mohamed Mamdouh Elsayed, MD
- Email: dr_mohamedmamdouh87@yahoo.com
- Phone: 00201068055103
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.