Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy

Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Study ID
NCT06573411
Phase
PHASE4
Status
Recruiting
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Conditions

  • Primary Membranous Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ACEI/ARB+ finerenone — DRUG
    The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD.
  • ACEI/ARB — DRUG
    Control patients will be administered maximum tolerable dose of ACEI/ARB.

Study Details

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.

Key Dates

Start date
Sep 30, 2024
Status verified
Apr 2026
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ACEI/ARB+finerenone
    The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD.
  • Active Comparator: ACEI/ARB
    Control patients will be administered maximum tolerable dose of ACEI/ARB.

Primary Outcome Measure

Relative change in urinary protein content from baseline to 24 weeks. [ Time Frame: 24 weeks ]

Central Contacts

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