Glomerulonephritis
Conditions
Keywords
finerenone, proteinuria, GFR progression, glomerulonephritis
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.
Interventions
DRUGFinerenone
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 9 months.
DRUGPlacebo
50 patients with biopsy proven glomerulonephritis who will receive placebo once daily in addition to their regular treatment protocol (RAAS blockers ± immunosuppression) for 9 months.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This research is a prospective randomized multicentric clinical trial in which 100 patients with biopsy proven glomerulonephritis (exception is nephrotic patients with positive anti-PLA2R indicative of primary membranous) will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1. * Group A: 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 9 months. * Group B: 50 patients with biopsy proven glomerulonephritis who will receive placebo once daily in addition to their regular treatment protocol (RAAS blockers ± immunosuppression) for 9 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| - Change in kidney function | 9 months | By assessing change in eGFR |
| - Change in proteinuria | 9 months | By assessing change in protein to creatinine ratio |
| Change in kidney function | 9 months | By assessing change in serum creatinine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - Occurrence of hyperkalemia (potassium level >5 mEq/L) | 9 months | By assessing serum K at baseline, then monthly |
| - Need for hospitalization | 9 months | By assessing the need for hospital admission |
| - Serious adverse events | 9 months | By reporting any serious adverse events during and after study for 2 weeks. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMohamed Mamdouh Elsayed, MD
Associate professor
Outcome results
None listed