Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy: A Prospective, Randomized, Controlled, Multicenter Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Relative change in urinary protein content from baseline to 6 months.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ACEI/ARB
Control patients will be administered maximum tolerable dose of ACEI/ARB.
干预措施: ACEI/ARB (Drug)
ACEI/ARB+finerenone
The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD.
干预措施: ACEI/ARB+ finerenone (Drug)
结局指标
主要结局
Relative change in urinary protein content from baseline to 6 months.
时间窗: 6 months
To evaluate the effects of ACEI/ARB combined with finerenone on proteinuria in patients with PMN compared to ACEI/ARB alone.
Relative change in urinary protein content from baseline to 24 weeks.
时间窗: 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.
次要结局
未报告次要终点
研究者
Wei Chen
professor
First Affiliated Hospital, Sun Yat-Sen University