Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis

Phase 2RecruitingNCT06835322

Alexandria University100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Glomerulonephritis

Interventions

FinerenoneDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Faculty of Medicine, Aexandria University

Alexandria, Egypt

RECRUITING

Outcomes

Primary Outcomes

- Change in kidney function

By assessing change in eGFR

Time frame: 6 months

- Change in proteinuria

By assessing change in protein to creatinine ratio

Time frame: 6 months

Change in kidney function

By assessing change in serum creatinine

Time frame: 6 months

Secondary Outcomes

- Occurrence of hyperkalemia (potassium level >5 mEq/L)

By assessing serum K at baseline, then monthly

Time frame: 6 months

- Need for hospitalization

By assessing the need for hospital admission

Time frame: 6 months

- Serious adverse events

By reporting any serious adverse events during and after study for 2 weeks.

Time frame: 6 months

Central Contacts

Mohamed Mamdouh Elsayed, MD

CONTACT

00201068055103 dr_mohamedmamdouh87@yahoo.com

Data from ClinicalTrials.gov

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