Finerenone for primary membranous nephropathy: efficacy and safety

Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy: A Prospective, Randomized, Controlled, Multicenter Clinical Study

This trial tests whether adding finerenone to standard ACEI/ARB treatment lowers urine protein over six months in adults with primary membranous nephropathy.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06573411 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, multicenter, controlled trial enrolling 116 adults with primary membranous nephropathy who have been on the maximum tolerated dose of an ACE inhibitor or ARB for at least four weeks. Participants are randomized 1:1 to continue ACEI/ARB alone or to receive finerenone 20 mg once daily in addition to ACEI/ARB. The primary endpoint is the relative change in urinary protein from baseline to six months, with eligibility restricted to patients with 1.0–5.0 g/day proteinuria and eGFR ≥60 mL/min/1.73 m2. Blood pressure must be controlled (≤140/90 mmHg) and patients with secondary causes of membranous nephropathy or diabetes are excluded.

Who should consider this trial

Good fit: Adults aged 18–75 with biopsy-proven primary membranous nephropathy, 1.0–5.0 g/day proteinuria, eGFR ≥60, BP ≤140/90 mmHg, and on the maximum tolerated ACEI/ARB for ≥4 weeks are ideal candidates.

Not a fit: Patients with type 1 or type 2 diabetes, secondary membranous nephropathy, uncontrolled hypertension, recent immunosuppressive or biologic therapy, or eGFR below 60 are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding finerenone could reduce proteinuria and help preserve kidney function in people with primary membranous nephropathy.

How similar studies have performed: Mineralocorticoid receptor antagonists have reduced proteinuria and improved kidney outcomes in other CKD populations (for example, finerenone in FIDELIO-DKD), but finerenone specifically for primary membranous nephropathy is a novel application with limited prior data.

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.

Where this trial is running

Guangzhou, Guangdong

• Wei Chen — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Wei Chen

Conditions Primary Membranous Nephropathy; finerenone; urinary protein