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

NCT07830433 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HS006-302
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Membranous Nephropathy

Outcome Measures

Primary Outcomes (1)

• The proportion of participants who achieved Complete Response (CR) at week 104

  The proportion of participants who achieved Complete Response (CR) at week 104

  Week 104

Study Arms (2)

Zuberitamab 1000mg

EXPERIMENTAL

Drug: Zuberitamab 1000mg

cyclosporine

ACTIVE COMPARATOR

Drug: Cyclosporine

Interventions

Zuberitamab 1000mg DRUG

administered at week0, week2, week24, week26 and week52

Zuberitamab 1000mg

Cyclosporine DRUG

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

cyclosporine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Two separate 24-hour urine protein tests performed during screening show elevated results, meeting the protocol-specified criteria:
• Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula (Levey, et al., 2009) ≥40 mL/min/1.73m²;
• If the patient is taking angiotensin-converting enzyme inhibitors (ACEi), angiotensin II receptor blockers (ARB), sodium-glucose cotransporter 2 (SGLT-2) inhibitors, or finerenone, the medication dose must remain stable for at least 4 weeks before screening (adherence to medication \>50% of this period is considered stable).
• Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and prior to the first administration of investigational product (Day 1 \[D1\], with an allowable time window of -7 days). Women of childbearing potential and male patients must agree to use effective contraception from the date of signing the informed consent form until 6 months after the last dose of investigational product.
• Women of childbearing potential are defined as all women who have reached menarche and have not undergone sterilization procedures (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) and are not postmenopausal. Postmenopausal women are defined as women with ≥12 consecutive months of amenorrhea without an alternative identifiable cause; OR women with irregular menstrual cycles receiving hormone replacement therapy (HRT) whose serum follicle-stimulating hormone (FSH) level is \>35 mIU/mL.
• Women using oral, implantable, or injectable contraceptives, or contraceptive methods such as intrauterine devices, diaphragms, condoms, and spermicides; or women practicing abstinence or whose sexual partner has undergone sterilization (e.g., vasectomy) shall still be classified as women of childbearing potential.

You may not qualify if:

• 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.
• Patients judged by the investigator to have prior resistance to cyclosporine or cyclophosphamide, or resistance (lack of response) to anti-CD20 therapy or any other B-cell depleting therapy.
• Prior receipt of any of the following therapeutic agents for membranous nephropathy:
• ② Immunosuppressants including mycophenolate mofetil, tacrolimus, cyclosporine, tripterygium wilfordii, etc., within 1 month before screening (if administered for ≤7 days, screening may be performed after drug discontinuation).
• ③ Alkylating agents (e.g., cyclophosphamide, chlorambucil, etc.) or traditional Chinese medicines with unknown ingredients within 6 months before screening.
• ④ Any anti-CD20 therapy within 9 months before screening, or any other B-cell depleting therapy or targeted therapy inhibiting antibody production (e.g., belimumab, etc.) within 6 months before screening.
• The 24-hour urine protein or urine protein-creatinine ratio (UPCR) at screening or baseline decreased by \>50% compared with the 24-hour urine protein or UPCR level within 6 months prior to randomization, and the investigator assesses a trend of spontaneous remission.
• Any abnormal laboratory result at screening as follows:
• Hepatic impairment defined as AST or ALT \> 2× upper limit of normal (ULN), or total bilirubin \>1.5×ULN.
• Without growth factor support or blood transfusion: total white blood cell count \<3.0×10⁹/L, absolute neutrophil count \<1.5×10⁹/L, platelet count \<75×10⁹/L, or hemoglobin \<90 g/L.
• Virology test results at screening:
• Positive hepatitis B surface antigen (HBsAg).

Sponsors & Collaborators

• BioRay Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Xiaoqiang Ding, Doctor

CONTACT

+8613601968215; Ding.Xiaoqiang@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)