This is a randomized, open-label, cyclosporine-controlled, multicenter Phase III study. It aims to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of zuberitamab versus cyclosporine in patients with primary membranous nephropathy, and provide evidence to support the expansion of zuberitamab's indication for primary membranous nephropathy. Approximately 150 study participants are expected to be enrolled in this trial and randomized in a 1:1 ratio to the HS006 1000 mg group (treatment group) and the cyclosporine group (control group), with 75 participants in each arm.
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;
Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula (Levey, et al., 2009) ≥40 mL/min/1.73m²;
Secondary membranous nephropathy (e.g., due to malignancy, systemic autoimmune diseases, infection, medications, etc.).
Concurrent other types of glomerulonephritis (e.g., IgA nephropathy), or renal pathological lesions including interstitial nephritis, glomerulosclerosis, etc., involving >50% of renal tissue that may affect prognosis.
Patients with type 1 diabetes mellitus, or type 2 diabetes mellitus complicated with diabetic nephropathy (patients with type 2 diabetes must provide a renal biopsy report obtained within 1 year prior to screening).
History of severe hypersensitivity to rituximab or other human-mouse chimeric antibodies (e.g., anaphylactic shock and angioedema), or known hypersensitivity to any ingredient or excipient of the investigational product.
Parallel
Zuberitamab 1000mg
Drugadministered at week0, week2, week24, week26 and week52
Cyclosporine
DrugInitial dose of 3.5 mg/kg/d, oral administration, divided into two doses, taken 12 hours apart (Q12h)
The proportion of participants who achieved Complete Response (CR) at week 104
The proportion of participants who achieved Complete Response (CR) at week 104
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
