Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy

Sun Yat-sen University

Status and phase

Not yet enrolling

Phase 4

Conditions

Primary Membranous Nephropathy

Treatments

Drug: ACEI/ARB+ finerenone

Drug: ACEI/ARB+ Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06573411

FIRPRO-PMN

Details and patient eligibility

About

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.

Full 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.

Enrollment

88 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.