Clinical trial NCT06573411: Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy
Official title: Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Primary Membranous Nephropathy
Keywords: finerenone
urinary protein
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Relative change in urinary protein content from baseline to 6 months.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: