Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06573411

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

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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

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