Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy

NCT ID: NCT06573411

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-10-30

Brief Summary

This is a prospective, randomized, multicenter, double-blinded, placebo-controlled trial. Eighty-eight 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 and a placebo. The primary endpoint is the relative change in urinary protein content from baseline to 6 months.

Detailed Description

After more than 4 weeks of maximum tolerated dose of ACEI/ARB, the patients will be randomly divided into the control and intervention groups in a 1:1 ratio in a double-blinded manner. The intervention group will then be administered finerenone 20 mg QD, while control cases will receive a placebo.

Conditions

Primary Membranous Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ACEI/ARB+finerenone

The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD.

Group Type: EXPERIMENTAL

ACEI/ARB+ finerenone

Intervention Type: DRUG

The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD.

ACEI/ARB+Placebo

Control patients will be administered maximum tolerable dose of ACEI/ARB and a placebo.

Group Type: PLACEBO_COMPARATOR

ACEI/ARB+ Placebo

Intervention Type: DRUG

Control patients will be administered maximum tolerable dose of ACEI/ARB and a placebo.

Interventions

ACEI/ARB+ finerenone

The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD.

Intervention Type: DRUG

ACEI/ARB+ Placebo

Control patients will be administered maximum tolerable dose of ACEI/ARB and a placebo.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Wei Chen

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FIRPRO-PMN

Identifier Type: -

Identifier Source: org_study_id