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NOT YET RECRUITING
NCT07830433
PHASE3

Evaluation of the Efficacy of Zuberitamab Injection in Patients With Primary Membranous Nephropathy

Sponsor: BioRay Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-10

Completion Date

2029-12

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

DRUG

Zuberitamab 1000mg

administered at week0, week2, week24, week26 and week52

DRUG

Cyclosporine

Initial dose of 3.5 mg/kg/d, oral administration, divided into two doses, taken 12 hours apart (Q12h)

Locations (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China