NCT06573411 Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy
| NCT ID | NCT06573411 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University |
| Condition | Primary Membranous Nephropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 116 participants in total. It began in 2024-09-30 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06573411 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Membranous Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06573411 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06573411 currently recruiting?
Yes, NCT06573411 is actively recruiting participants. Contact the research team at chenwei99@mail.sysu.edu.cn for enrollment information.
Where is the NCT06573411 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06573411 clinical trial?
NCT06573411 is sponsored by First Affiliated Hospital, Sun Yat-Sen University. The trial plans to enroll 116 participants.