Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy

Phase 4RecruitingNCT06573411

First Affiliated Hospital, Sun Yat-Sen University116 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

116

Conditions

Primary Membranous Nephropathy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: 1. Hemoglobin levels \<80 g/L; 2. Platelet count \<80×109/L; 3. Neutrophil count \<1.0×109/L; 4. 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.

Outcomes

Primary Outcomes

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.

Time frame: 24 weeks