A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy

Inclusion criteria

• ✓. Voluntarily sign the informed consent form and be able to complete the trial according to the protocol;
• ✓. The age range is between 18 and 75 years old (including the critical value, subject to the day of signing the informed consent form), regardless of gender;
• ✓. Diagnosed with primary (idiopathic) membranous nephropathy by renal biopsy before or during screening;
• ✓. During the screening period and baseline visit, the urinary protein/creatinine ratio (UPCR) based on 24-hour urine collection should be ≥ 3.5 g/g;
• ✓. The estimated glomerular filtration rate (eGFR) using the CKD-EPI formula is ≥ 40mL/min/1.73m2;
• ✓. If you are taking angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor antagonists (ARBs), you need to maintain a stable dosage for at least 4 weeks before screening;
• ✓. Women with fertility who have a negative pregnancy test during the screening period and before the first treatment with the investigational drug (D1 \[allowed -7-day time window\]) must agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last administration; Women with fertility include all women who have had their first menstrual period and have not undergone sterilization procedures (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or have not yet reached menopause. Menopausal women are defined as having amenorrhea for at least 12 consecutive months without any other reason; Women with irregular menstrual cycles undergoing hormone replacement therapy (HRT) and serum follicle stimulating hormone (FSH) levels\>35 mIU/mL; Women who are using oral, implanted, or injectable contraceptives, or using methods such as intrauterine devices, vaginal diaphragms, condoms, and spermicides for contraception, or women who have limited sexual activity and have had their sexual partners sterilized (such as vasectomy), should be considered to have fertility.

Exclusion criteria