This is a prospective, randomized, multicenter, controlled trial. One hundred sixteen patients with primary membranous nephropathy (PMN) will be randomly divided into the intervention and control groups. The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD. Control patients will be administered maximum tolerable dose of ACEI/ARB. The primary endpoint is the relative change in urinary protein content from baseline to 6 months.
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.
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.
Parallel
ACEI/ARB+ finerenone
DrugThe intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD.
ACEI/ARB
DrugControl patients will be administered maximum tolerable dose of ACEI/ARB.
Relative change in urinary protein content from baseline to 24 weeks.
To evaluate the effects of ACEI/ARB combined with finerenone on proteinuria in patients with PMN compared to ACEI/ARB alone. The primary outcome of this study is the change in 24-hour urinary protein excretion (24h UTP) from baseline at week 24. The primary analysis of the study is planned to be performed using an Analysis of Covariance (ANCOVA) model. In this model, the treatment group is included as a fixed effect factor, the 24h UTP value at week 24 serves as the dependent variable, and the baseline UTP level is adjusted as a covariate. The main purpose of the analysis is to compare the changes in UTP at week 24 among different treatment groups while controlling for baseline differences between patients. The model will estimate the least squares means (LS-means) and provide the treatment difference between each pair of treatment groups, along with their two-sided 95% confidence intervals and p-values.
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