Primary Membranous NephropathyPhase 2/3NCT06470191
A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.
A Phase 2/3 study testing B007 and Cyclosporin Capsules in people with Primary Membranous Nephropathy, run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 21 sites in China.
Trial summary
To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- B007 and Cyclosporin Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 21 sitesChina
- Study dates
- 30 Jul 2024to 31 Dec 2026
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
- Subjects with glomerular filtration rate（eGFR） ≥ 45 mL/min/1.73 m2.
- If taking Angiotensin converting enzyme inhibitors/angiotensin II receptor antagonists/sodium-glucose cotransporter 2 inhibitors/endothelin inhibitors, a stable dose within 4 weeks before randomization;
- Subjects with 24-hour elevated urinary protein in accordance with the prescribed conditions;
- Subjects whose laboratory test results meet the prescribed standards during the screening period;
- Subjects who have fully understood this study and voluntarily signed the informed consent form；
- Subjects who are able to follow the study protocol as judged by the investigator.
Who cannot join
- Subjects with secondary membranous nephropathy or primary membranous nephropathy whose pathological reports suggest concomitant crescent bodies;
- Subjects identified by the investigator as previously resistant to CD20 monoclonal antibody or cyclosporine;
- Subjects who have received medication prescribed for membranous nephropathy;
- Subjects with concomitant prescribed diseases;
- Subjects with a known history of severe allergic reactions to humanized monoclonal antibodies, or known allergies to any component of cyclosporine or B007;
- Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
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- Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency or suffer from other acquired or congenital immunodeficiency diseases;
- Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
- Subjects with CD4+ T lymphocyte count < 400 cells/μL;
- Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;
- For male subjects who have not been sterilized: those who do not consent to the use of barrier contraception during the study period and for at least 12 months after the last administration of the study drug, and who do not consent to the use of other contraceptive methods by their spouses;
- Other conditions unsuitable for participation in this study determined by the Investigator.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
China21 sites, 21 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing
Yuehong Li
- Recruiting
Peking university first hospital
Beijing
Minghui Zhao
- Recruiting
The Second Norman Bethune Hospital of Jilin University
Changchun
Ping Luo
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
Wei Chen
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou
Haibo Long
- Recruiting
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou
Hua Li
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Heng Li
- Recruiting
Shandong Provincial Hospital
Jinan
Rong Wang
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning
Zhenhua Yang
- Recruiting
Affiliated Hospital of Nantong University
Nantong
Xinzhong Huang
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao
Guangqun Xing
- Recruiting
Northern Theater Command General Hospital
Shenyang
Yanning Zhang
- Recruiting
Shengjing Hospital affiliated to China Medical University
Shenyang
Hua Zhou
- Recruiting
Peking University Shenzhen Hospital
Shenzhen
Zibo Xiong
- Recruiting
Renmin Hospital of Wuhan University
Wuhan
Dingping Yang
- Recruiting
Wuxi People's Hospital
Wuxi
Bin Liu
- Recruiting
Xi'an Daxing Hospital
Xi'an
Chengqun Zhao
- Recruiting
The Second Affiliated Hospital of Xingtai Medical college
Xingtai
Huixiao Zheng
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou
Guangyu Bi
- Recruiting
Yantai Yuhuangding Hospital
Yantai
Peng Li
- Recruiting
The First People's Hospital of Zigong
Zigong
Yan Hao
About this study
Official title: A Multicenter, Randomized, Controlled, Open Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 Versus Cyclosporine in the Treatment of Primary Membranous Nephropathy.
To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy
- Conditions
- Primary Membranous Nephropathy
- Being tested
- B007, Cyclosporin Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B007Drug
B007： Subcutaneous injection was administered on days 1 and 15
Cyclosporin CapsulesDrug
Cyclosporin Capsules： Orally, 3.5 mg/kg/d；
| Study group | Role | What they receive |
|---|---|---|
| B007 | Experimental | Not described Receives: Drug: B007 |
| Cyclosporin Capsules | Active comparator | Not described Receives: Drug: Cyclosporin Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR（Overall Remission Rate）
Measured: Approximately 2 years
Secondary outcomes (3)
CRR（Complete Remission Rate）
Measured: Approximately 2 years
PRR（Partial Remission Rate）
Measured: Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start30 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470191
- Sponsor's protocol ID
- SPH-B007-302
- Status last verified
- Apr 2026
- First submitted
- 17 Jun 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Open Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 Versus Cyclosporine in the Treatment of Primary Membranous Nephropathy.
- ClinicalTrials.gov ID
- NCT06470191
- Acronym / sponsor ID
- SPH-B007-302
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jun 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.
To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B007 | Experimental | Drug: B007 |
| Cyclosporin Capsules | Active comparator | Drug: Cyclosporin Capsules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
- Subjects with glomerular filtration rate（eGFR） ≥ 45 mL/min/1.73 m2.
- If taking Angiotensin converting enzyme inhibitors/angiotensin II receptor antagonists/sodium-glucose cotransporter 2 inhibitors/endothelin inhibitors, a stable dose within 4 weeks before randomization;
- Subjects with 24-hour elevated urinary protein in accordance with the prescribed conditions;
- Subjects whose laboratory test results meet the prescribed standards during the screening period;
Key exclusion criteria (12 listed)
- Subjects with secondary membranous nephropathy or primary membranous nephropathy whose pathological reports suggest concomitant crescent bodies;
- Subjects identified by the investigator as previously resistant to CD20 monoclonal antibody or cyclosporine;
- Subjects who have received medication prescribed for membranous nephropathy;
- Subjects with concomitant prescribed diseases;
- Subjects with a known history of severe allergic reactions to humanized monoclonal antibodies, or known allergies to any component of cyclosporine or B007;
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 |
|---|---|---|
| B007B007： Subcutaneous injection was administered on days 1 and 15 | Drug | B007 |
| Cyclosporin CapsulesCyclosporin Capsules： Orally, 3.5 mg/kg/d； | Drug | Cyclosporin Capsules |
Primary outcome
ORR（Overall Remission Rate）
Time frame: Approximately 2 years
3 secondary outcomes
CRR（Complete Remission Rate）
Time frame: Approximately 2 years
PRR（Partial Remission Rate）
Time frame: Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 2 years
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 5 May 2026.
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing B007 and Cyclosporin Capsules in people with Primary Membranous Nephropathy, run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 21 sites 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 12 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: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Minghui Zhao (0086- 010-66119025, bdyyec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR（Overall Remission Rate） (time frame: Approximately 2 years). 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 5 May 2026.