ACEI/ARB+ finerenone: The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD.
ACEI/ARB: Control patients will be administered maximum tolerable dose of ACEI/ARB.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Relative change in urinary protein content from baseline to 24 weeks. — 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.
Trial sites (1)
Facility
City
Region
Status
Wei Chen
Guangzhou
Guangdong
Recruiting
More First Affiliated Hospital, Sun Yat-Sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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