ClinicalTrials.gg
Not yet recruitingNCT07830433Updated Sep 21, 2026

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

A Phase 3 interventional study of Zuberitamab 1000mg and Cyclosporine in Primary Membranous Nephropathy, sponsored by BioRay Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by BioRay Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 60 studies in Glomerulonephritis, Membranous with a site in China — 29 open to participants now, 37 under way, 10 of them phase 3. Glomerulonephritis, Membranous · China.

Planned enrollment
11th of 50
150 · median 77
Started
2026
with 5 others
Phase 3
9 of 60
4 open now
Primary completion
2029-12
later than 35 of 36 live
Registered
60th of 60
by date
Lead sponsor
2 of 60
BioRay Pharmaceutical Co., Ltd.

Among the 60 studies in Glomerulonephritis, Membranous with a site in China, this one is the 11th largest by planned enrollment of the 50 interventional ones, is one of 6 that started in 2026, is one of 9 in phase 3, reaches primary completion later than 35 of the 36 other live ones, and was the 60th registered.

By phase

60 studies; the count open now beside each. This study's row is marked.

Phase 211 · 6 open
No phase10 · 1 open
Observational10 · 4 open
Phase 3this study9 · 4 open
Phase 17 · 6 open
Phase 47 · 4 open
Phase 2/34 · 3 open
Phase 1/22 · 1 open

By the year they started

First in 1990; this study’s year is marked. 6 started in 2026.

Size and results

Median enrollment 77 across the 50 interventional studies, 241 across the 10 observational. Of the 13 that completed or were terminated, 1 (8%) have results posted.

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02

Study 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.

03

Conditions studied

  • Primary Membranous Nephropathy
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Voluntarily sign the 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 before or during screening;
  • Two separate 24-hour urine protein tests performed during screening show elevated results, meeting the protocol-specified criteria:
  • Estimated (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 (WOCBP) must have a negative pregnancy test at screening and prior to the first administration of product (Day 1 [D1], with an allowable time window of -7 days). Women of childbearing potential and male patients must agree to use effective 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 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.

Exclusion criteria

Exclusion Criteria:

  • Secondary membranous nephropathy (e.g., due to , systemic 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 report obtained within 1 year prior to screening).
  • History of severe to rituximab or other human-mouse chimeric antibodies (e.g., anaphylactic shock and angioedema), or known hypersensitivity to any ingredient or of the 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:

    ① at conventional doses (oral, intravenous, intramuscular, etc.) within 1 month before screening (exception: glucocorticoid dose equivalent to prednisone \<1.0 mg/kg/day administered for ≤7 days is not an exclusion criterion); pulse glucocorticoid therapy within 3 months before screening (methylprednisolone ≥250 mg/day for ≥3 consecutive days).

    ② 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:

    1. Hepatic impairment defined as or ALT > 2× (ULN), or total >1.5×ULN.
    2. Without growth factor support or blood transfusion: total white blood cell count \<3.0×10⁹/L, \<1.5×10⁹/L, count \<75×10⁹/L, or \<90 g/L.
  • Virology test results at screening:

    1. Positive surface antigen (HBsAg).
    2. Negative HBsAg but positive hepatitis B core antibody, with further HBV DNA level exceeding the upper reference limit of the local hospital.
    3. Patients with positive virus (HCV) antibody and positive HCV RNA.
    4. Positive (HIV) serology.
  • Suspected active tuberculosis based on medical history or tuberculosis screening.
  • Patients with known active bacterial, viral, fungal, mycobacterial, parasitic or other infections (excluding superficial onychomycosis) within 4 weeks before the baseline visit; or history of any major systemic infection requiring intravenous antibiotic therapy or hospitalization, or severe chronic/recurrent infection.
  • Other severe diseases that may preclude participation in this trial, such as uncontrolled diabetes; severe cardiac dysfunction ( class II or higher); acute coronary syndrome within the previous 6 months; coronary revascularization including stent implantation, coronary artery bypass grafting, and other cardiac or great vessel surgery within the previous 6 months; severe arrhythmias including frequent ventricular premature beats, ventricular tachycardia, rapid atrial fibrillation/flutter, severe bradycardia; uncontrolled hypertension (>150/100 mmHg); severe respiratory diseases (e.g., history of obstructive lung disease and bronchospasm), etc.
  • History of malignant neoplasm within the past 5 years or active malignancy at present (except for cutaneous squamous cell carcinoma, basal cell carcinoma, and cervical carcinoma in situ that have been successfully treated with no evidence of recurrence).
  • Patients who received live/attenuated vaccines within 4 weeks before the baseline visit, or plan to receive during the study period.
  • History of organ/tissue transplantation or stem cell transplantation. 16. Patients who underwent any major surgical procedure within 12 weeks before the baseline visit or plan to undergo major surgery during the study.
  • History of drug abuse or alcohol abuse within 6 months before the baseline visit, as judged by the investigator.
  • Pregnant or lactating women.
  • Participation in another clinical drug trial, where the time from last study drug administration to screening is less than 30 days or 5 half-lives of the prior investigational product (whichever is longer); or plan to participate in another clinical drug trial during this study.
  • Any other condition or symptom that, in the opinion of the investigator, renders the subject unsuitable for participation in this study.
Terms in these criteria, in plain language(25)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Zuberitamab 1000mg

    Drug: Zuberitamab 1000mg

  • Active comparator
    cyclosporine

    Drug: Cyclosporine

Interventions

  • administered at week0, week2, week24, week26 and week52

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

06

What researchers measure

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

    Time frame: Week 104

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2029, 38 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2026
First posted
Sep 21, 2026
StartEst.
Oct 2026
Primary completionEst.
Dec 2029
CompletionEst.
Dec 2029
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07830433
Lead sponsor
BioRay Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Sep 21, 2026

Study contacts

Xiaoqiang Ding, Doctor
Contact
Ding.Xiaoqiang@zs-hospital.sh.cn
+8613601968215

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Zuberitamab

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