Primary Membranous NephropathyPhase 2NCT06642909
A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy
A Phase 2 study testing Zuberitamab 600mg, Zuberitamab 1000mg and cyclosporine in people with Primary Membranous Nephropathy, run by BioRay Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- Zuberitamab 600mg, Zuberitamab 1000mg and cyclosporine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2024to 10 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- During the screening period and baseline visit, the urinary protein/creatinine ratio (UPCR) based on 24-hour urine collection should be ≥ 3.5 g/g;
- The estimated glomerular filtration rate (eGFR) using the CKD-EPI formula is ≥ 40mL/min/1.73m2;
- If you are taking angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor antagonists (ARBs), you need to maintain a stable dosage for at least 4 weeks before screening;
- Women with fertility who have a negative pregnancy test during the screening period and before the first treatment with the investigational drug (D1 [allowed -7-day time window]) must agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last administration; Women with fertility include all women who have had their first menstrual period and have not undergone sterilization procedures (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or have not yet reached menopause. Menopausal women are defined as having amenorrhea for at least 12 consecutive months without any other reason; Women with irregular menstrual cycles undergoing hormone replacement therapy (HRT) and serum follicle stimulating hormone (FSH) levels>35 mIU/mL; Women who are using oral, implanted, or injectable contraceptives, or using methods such as intrauterine devices, vaginal diaphragms, condoms, and spermicides for contraception, or women who have limited sexual activity and have had their sexual partners sterilized (such as vasectomy), should be considered to have fertility.
Who cannot join
- Secondary membranous nephropathy (such as malignant tumors, systemic autoimmune diseases, drugs, etc.).
- People with type 1 diabetes or type 2 diabetes with diabetic nephropathy (type 2 diabetics need to have renal biopsy reports within 1 year before screening).
- Individuals with severe allergies to rituximab or other human mouse chimeric antibodies in the past (such as anaphylactic shock and angioedema) or known allergies to any ingredients or excipients of the investigational drug.
- Individuals who have previously been resistant to cyclosporine or cyclophosphamide, or resistant to CD20 or any other therapy that leads to B cell depletion (ineffective) are identified by investigators.
- Individuals with evidence of a >50% decrease in urine protein/creatinine ratio within the first 6 months of screening .
- There is no evidence during the screening period to suggest that the patient is positive for PMN related antibodies.
Show all 19Show fewer
- Any of the following abnormal laboratory test results during screening: a. Abnormal liver function, defined as AST or ALT values>2 x upper limit of normal (ULN), or total bilirubin values>1.5 x ULN; b. Total white blood cell count<3.0 x 109/L, absolute neutrophil count<1.5 x 109/L, platelet count<75 x 109/L, or hemoglobin<90g/L.
- Virological examination results during screening: a. Hepatitis B surface antigen (HBsAg) positive individuals; b. The patient is negative for hepatitis B surface antigen and positive for hepatitis B core antibody, and the result of further hepatitis B virus DNA test exceeds the upper limit of the hospital's reference value; c. Patients with positive hepatitis C virus (HCV) antibodies and HCV RNA; d. The human immunodeficiency virus (HIV) serum reaction is positive.
- Suspected active or latent tuberculosis patients based on medical history or tuberculosis screening.
- Individuals with known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding fungal infections of the nail bed) or any major systemic infection requiring intravenous antibiotic treatment or hospitalization within 4 weeks prior to the baseline visit.
- Other serious diseases that may restrict the subjects from participating in the test, such as uncontrollable diabetes; Severe heart failure (NYHA grade II or above); Acute coronary syndrome occurred within the past 6 months; Coronary revascularization such as stent implantation, coronary artery bypass surgery, and other heart and large vessel related surgeries within the past 6 months; Severe arrhythmias include frequent premature ventricular contractions, ventricular tachycardia, rapid atrial fibrillation/flutter, and severe bradycardia; Uncontrolled hypertension (greater than 150/100mmHg); Severe respiratory diseases (such as obstructive pulmonary disease and history of bronchospasm).
- Individuals who have had or currently have malignant tumors within the past 5 years (excluding skin squamous cell carcinoma, basal cell carcinoma, and cervical carcinoma in situ that have been successfully treated and have no evidence of recurrence).
- Those who have received live/attenuated vaccines within 4 weeks prior to the baseline visit, or those who plan to receive live vaccines during the study period;
- Received organ/tissue transplantation or stem cell transplantation.
- Perform any major surgical procedures within 12 weeks prior to the baseline visit or during the planned study period.
- According to the researchers' assessment, there is a clinically significant history of drug or alcohol abuse within the 6 months prior to the baseline visit.
- Pregnant or lactating women.
- For those who have participated in clinical trials of other drugs and have not been screened for more than 30 days since the last administration or have 5 half lives of the original investigational drug (whichever is longer), or plan to participate in another drug clinical trial during the study period.
- Researchers believe that there are other symptoms or conditions that are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Open Label, Cyclosporine Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Zuberitamab Injection (HS006) in Patients With Primary Membranous Nephropathy
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
- Primary Membranous Nephropathy
- Being tested
- Zuberitamab 600mg, Zuberitamab 1000mg, cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zuberitamab 600mgDrug
administered twice with a 2-week interval between each dose (i.e. D1, D15). One treatment cycle is 24 weeks
Zuberitamab 1000mgDrug
administered twice with a 2-week interval between each dose (i.e. D1, D15). One treatment cycle is 24 weeks
cyclosporineDrug
Initial dose of 3.5 mg/kg/d, oral administration, divided into two doses, taken 12 hours apart (Q12h)
| Study group | Role | What they receive |
|---|---|---|
| Zuberitamab 600mg | Experimental | Not described Receives: Drug: Zuberitamab 600mg |
| Zuberitamab 1000mg | Experimental | Not described Receives: Drug: Zuberitamab 1000mg |
| cyclosporine | Active comparator | Not described Receives: Drug: cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who achieved overall response (OR) in the urinary protein/creatinine ratio (UPCR) at week 76
The proportion of subjects who achieved overall response (OR) in the urinary protein/creatinine ratio (UPCR) at week 76
Measured: Week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start13 Nov 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioRay Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642909
- Sponsor's protocol ID
- HS006-MN-01
- Status last verified
- Nov 2025
- First submitted
- 13 Oct 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Label, Cyclosporine Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Zuberitamab Injection (HS006) in Patients With Primary Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT06642909
- Acronym / sponsor ID
- HS006-MN-01
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- BioRay Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zuberitamab 600mg | Experimental | Drug: Zuberitamab 600mg |
| Zuberitamab 1000mg | Experimental | Drug: Zuberitamab 1000mg |
| cyclosporine | Active comparator | Drug: cyclosporine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- During the screening period and baseline visit, the urinary protein/creatinine ratio (UPCR) based on 24-hour urine collection should be ≥ 3.5 g/g;
- The estimated glomerular filtration rate (eGFR) using the CKD-EPI formula is ≥ 40mL/min/1.73m2;
Key exclusion criteria (19 listed)
- Secondary membranous nephropathy (such as malignant tumors, systemic autoimmune diseases, drugs, etc.).
- People with type 1 diabetes or type 2 diabetes with diabetic nephropathy (type 2 diabetics need to have renal biopsy reports within 1 year before screening).
- Individuals with severe allergies to rituximab or other human mouse chimeric antibodies in the past (such as anaphylactic shock and angioedema) or known allergies to any ingredients or excipients of the investigational drug.
- Individuals who have previously been resistant to cyclosporine or cyclophosphamide, or resistant to CD20 or any other therapy that leads to B cell depletion (ineffective) are identified by investigators.
- Individuals with evidence of a >50% decrease in urine protein/creatinine ratio within the first 6 months of screening .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zuberitamab 600mgadministered twice with a 2-week interval between each dose (i.e. D1, D15). One treatment cycle is 24 weeks | Drug | Zuberitamab 600mg |
| Zuberitamab 1000mgadministered twice with a 2-week interval between each dose (i.e. D1, D15). One treatment cycle is 24 weeks | Drug | Zuberitamab 1000mg |
| cyclosporineInitial dose of 3.5 mg/kg/d, oral administration, divided into two doses, taken 12 hours apart (Q12h) | Drug | cyclosporine |
Primary outcome
The proportion of subjects who achieved overall response (OR) in the urinary protein/creatinine ratio (UPCR) at week 76
Time frame: Week 76
The proportion of subjects who achieved overall response (OR) in the urinary protein/creatinine ratio (UPCR) at week 76
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zuberitamab 600mg, Zuberitamab 1000mg and cyclosporine in people with Primary Membranous Nephropathy, run by BioRay Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects who achieved overall response (OR) in the urinary protein/creatinine ratio (UPCR) at week 76 (time frame: Week 76). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.