Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy

After more than 4 weeks of maximum tolerated dose of ACEI/ARB, the patients will be randomly divided into the control and intervention groups in a 1:1 ratio. The intervention group will then be administered finerenone 20 mg QD, while control cases will continue on their ACEI/ARB therapy.

Inclusion criteria

• Adults (age≥18,and ≤75) with primary MN.
• Administration of the maximum tolerable dose of ACEI/ARB for ≥4 weeks.
• BP ≤140/90 mmHg.
• Urine protein content of 1.0-5.0 g/d.
• eGFR ≥60 (CKD-EPI).
• Postmenopausal or postoperatively infertile status or on medical contraception (considering the potential risk of thromboembolism in patients with kidney disease) in women.
• Voluntary signing of informed consent.

Exclusion criteria

• Type 1 or type 2 diabetes. Patients with a recent history of steroid-induced diabetes were eligible with renal biopsy showing no evidence of secondary diabetic nephropathy within 6 months before the screening period.
• Patients with secondary membranous nephropathy (e.g., due to hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes).
• Uncontrolled arterial hypertension.
• Treatment with glucocorticoids, immunosuppressants and/or biological agents in the past 6 months.
• Treatment with any other study drug within the last month.
• Females with a positive pregnancy screening test, lactating or planning to become pregnant in the next 24 months. Female or male patients unwilling to use contraceptive methods throughout the study.
• A history of mental illness.
• Laboratory tests meeting the following criteria:

• Hemoglobin levels <80 g/L;
• Platelet count <80×109/L;
• Neutrophil count <1.0×109/L;
• Aspartate aminotransferase (AST) or amino aminotransferase (ALT) >2.5 times the upper limit of normal, except in relation to the primary disease.
• Very high-risk cases (life-threatening nephrotic syndrome or unexplained rapid deterioration of renal function).
• Unsuitability for inclusion in the trial as judged by the investigator.