Finerenone for primary membranous nephropathy: efficacy and safety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Wei Chen
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Wei Chen
• Email: chenwei99@mail.sysu.edu.cn
• Phone: 8602087769673

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Surovatamig for adults with anti‑PLA2R primary membranous nephropathy

  This study will test whether subcutaneous surovatamig is safe and can reduce heavy proteinuria in adults with anti‑PLA2R–positive primary membranous nephropathy.

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• SHR-2173 injections for adults with primary membranous nephropathy

  This Phase II test will try SHR-2173 injections in adults (18–75) with biopsy-proven primary membranous nephropathy to see if they are safe, reduce disease activity, and to measure how the drug acts in the body.

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• Povetacicept for people with primary membranous nephropathy

  This trial tests whether povetacicept is safe and helps people with primary membranous nephropathy, with tacrolimus listed as an intervention in the protocol.

  Recruiting at 116 sites Phase 2/3 Vertex Pharmaceuticals Incorporated · Montgomery, Alabama and 116 other locations · NCT07204275

• ALXN1920 for adults with primary membranous nephropathy

  This trial will test whether ALXN1920 reduces urine protein in adults with primary membranous nephropathy who are at high risk of progression compared with placebo.

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• Budoprutug for primary membranous nephropathy (Phase 2)

  This trial will test whether budoprutug, an anti-CD19 antibody given by IV, is safe and tolerated and may reduce proteinuria in adults with PLA2R-positive primary membranous nephropathy who still have high protein in their urine despite RAAS blockers.

  Recruiting at 35 sites Phase 2 Climb Bio, Inc. · Denver, Colorado and 37 other locations · NCT07096843

• Evaluating YK012 for treating primary membranous nephropathy

  This study is testing a new treatment called YK012 to see if it can help people with primary membranous nephropathy feel better and how safe it is to use.

  Recruiting Phase 1 Excyte Biopharma Ltd · Beijing, Beijing Municipality · NCT06982729

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.