Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy

Phase 4

Not yet recruiting

• Conditions: Primary Membranous Nephropathy
• Interventions: Drug: ACEI/ARB+ finerenone; Drug: ACEI/ARB+ Placebo

• Registration Number: NCT06573411
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-24
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Study Start: 2024-09-30
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACEI/ARB+finerenone	ACEI/ARB+ finerenone	The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD.
ACEI/ARB+Placebo	ACEI/ARB+ Placebo	Control patients will be administered maximum tolerable dose of ACEI/ARB and a placebo.

Primary Outcome Measures

Name	Time	Method
Relative change in urinary protein content from baseline to 6 months.	6 months	To evaluate the effects of ACEI/ARB combined with finerenone on proteinuria in patients with PMN compared to ACEI/ARB alone.