Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis

Phase 2

Recruiting

• Conditions: Glomerulonephritis
• Interventions: Drug: Finerenone; Drug: Placebo

• Registration Number: NCT06835322
• Lead Sponsor: Alexandria University

Brief Summary

This study aims to assess the effect of finerenone on proteinuria and GFR progression in patients with non-diabetic glomerulonephritis.

Detailed Description

In patients with type 2 diabetes and advanced CKD, finerenone resulted in lower risks of CKD progression and cardiovascular events. Mineralocorticoid receptor over activation in the kidney leads to inflammation and fibrosis with subsequent progressive kidney disease. Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, had more potent anti-inflammatory and ant fibrotic effects than steroidal mineralocorticoid receptor antagonists. Finerenone has been shown to reduce the urinary albumin-to-creatinine ratio in patients with CKD treated with an RAS blocker, while having smaller effects on serum potassium levels than spironolactone.

Glomerulonephritis (GN) is an inflammation affecting kidney glomeruli, and is considered an important cause of CKD. Reducing proteinuria is one of the main therapeutic targets in patients with GN.

Study Timeline

• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-13
• Study Start: 2025-02-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-23
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-08-20
• Study Completion: 2025-09-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interventional	Finerenone	50 patients with biopsy proven glomerulonephritis who will receive 10 - 20 mg finerenone once daily orally in addition to their regular treatment protocol (RAAS blockers ± immunosuppression) for 6 months.
placebo	Placebo	50 patients with biopsy proven glomerulonephritis who will receive placebo once daily in addition to their regular treatment protocol (RAAS blockers ± immunosuppression) for 6 months.

Primary Outcome Measures

Name	Time	Method
- Change in kidney function	6 months	By assessing change in eGFR
- Change in proteinuria	6 months	By assessing change in protein to creatinine ratio
Change in kidney function	6 months	By assessing change in serum creatinine

Secondary Outcome Measures

Name	Time	Method
- Occurrence of hyperkalemia (potassium level >5 mEq/L)	6 months	By assessing serum K at baseline, then monthly
- Need for hospitalization	6 months	By assessing the need for hospital admission
- Serious adverse events	6 months	By reporting any serious adverse events during and after study for 2 weeks.

Trial Locations

Locations (1)

Faculty of Medicine, Aexandria University; 🇪🇬 Alexandria, Egypt