Actively Recruiting
Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy: A Prospective, Randomized, Controlled, Multicenter Clinical Study
Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2026-04-08
116
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the efficacy and safety of finerenone in patients with primary membranous nephropathy (PMN), a kidney condition. The trial is a prospective, randomized, controlled, multicenter study involving 116 patients. It compares the effects of adding finerenone to the current treatment of maximum tolerated doses of ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) against ACEI/ARB treatment alone. The primary goal is to measure the change in urinary protein levels over six months. Participants will first receive at least four weeks of maximum tolerated ACEI/ARB therapy. Then, they will be randomly assigned to either continue ACEI/ARB alone or receive ACEI/ARB plus finerenone 20 mg once daily. The study compares these two groups over a 24-week period, focusing on how their urinary protein content changes. The design includes no masking or blinding and uses random allocation to study groups. During the study, participants will undergo regular assessments including urine tests to measure protein levels, blood pressure monitoring, and kidney function tests such as estimated glomerular filtration rate (eGFR). Researchers will track changes from baseline to 24 weeks to evaluate treatment effects. The total participation time spans from initial treatment through six months of follow-up, with safety and adherence monitored throughout the study.
CONDITIONS
Brief Title
Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years with primary membranous nephropathy
- Have taken maximum tolerable dose of ACEI/ARB for at least 4 weeks
- Blood pressure controlled at or below 140/90 mmHg
- Urine protein content between 1.0 and 5.0 grams per day
- Estimated glomerular filtration rate (eGFR) of at least 60 (CKD-EPI)
- Women must be postmenopausal, surgically infertile, or using medical contraception
- Voluntary signing of informed consent
You will not qualify if you...
- Diagnosis of type 1 or type 2 diabetes, except recent steroid-induced diabetes with no secondary diabetic nephropathy
- Secondary membranous nephropathy due to other diseases or causes
- Uncontrolled high blood pressure
- Use of glucocorticoids, immunosuppressants, or biological agents in the past 6 months
- Use of any other study drug within the last month
- Pregnant, breastfeeding, or planning pregnancy within 24 months
- Unwillingness to use contraception during the study
- History of mental illness
- Low blood counts or abnormal liver enzyme levels beyond specified thresholds
- Life-threatening nephrotic syndrome or rapid kidney function decline
- Investigator's judgment deeming unsuitability for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants receive either finerenone 20 mg daily plus maximum tolerable dose of ACEI/ARB or continue their ACEI/ARB therapy alone.
Visits occur during the 24-week treatment period
Trial Site Locations
Total: 1 location
1
Wei Chen
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
W
Wei Chen
Q
Qiong Wen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here