Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis

Alexandria University

Status and phase: Enrolling; Phase 2

Conditions: Glomerulonephritis

Treatments: Drug: Placebo; Drug: Finerenone

Study type: Interventional

Funder types: Other

Identifiers

NCT06835322

Finerenone and GN

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

interventional

Experimental group

Description:

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.

Treatment:

Drug: Finerenone

placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo