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

NCT06642909 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-11-20

No results posted yet for this study

Summary

This study is a multicenter, randomized, open label, cyclosporine controlled Phase II trial aimed at evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of Zuberitamab in patients with primary membranous nephropathy, and exploring the Phase III dosing regimen, sample size, and endpoint evaluation time

Conditions

Interventions

DRUG

Zuberitamab 600mg

administered twice with a 2-week interval between each dose (i.e. D1, D15). One treatment cycle is 24 weeks

DRUG

Zuberitamab 1000mg

administered twice with a 2-week interval between each dose (i.e. D1, D15). One treatment cycle is 24 weeks

DRUG

cyclosporine

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

Sponsors & Collaborators

  • BioRay Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2027-03-31
Completion
2027-05-10

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06642909 on ClinicalTrials.gov