A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.
NCT ID: NCT06470191
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
216 participants
INTERVENTIONAL
2024-07-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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B007
B007
B007： Subcutaneous injection was administered on days 1 and 15
Cyclosporin Capsules
Cyclosporin Capsules
Cyclosporin Capsules： Orally, 3.5 mg/kg/d；
Interventions
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B007
B007： Subcutaneous injection was administered on days 1 and 15
Cyclosporin Capsules
Cyclosporin Capsules： Orally, 3.5 mg/kg/d；
Eligibility Criteria
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Inclusion Criteria
2. Subjects with glomerular filtration rate（eGFR） ≥ 45 mL/min/1.73 m2.
3. 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;
4. Subjects with 24-hour elevated urinary protein in accordance with the prescribed conditions;
5. Subjects whose laboratory test results meet the prescribed standards during the screening period;
6. Subjects who have fully understood this study and voluntarily signed the informed consent form；
7. Subjects who are able to follow the study protocol as judged by the investigator.
Exclusion Criteria
2. Subjects identified by the investigator as previously resistant to CD20 monoclonal antibody or cyclosporine;
3. Subjects who have received medication prescribed for membranous nephropathy;
4. Subjects with concomitant prescribed diseases;
5. Subjects with a known history of severe allergic reactions to humanized monoclonal antibodies, or known allergies to any component of cyclosporine or B007;
6. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
7. 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;
8. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
9. Subjects with CD4+ T lymphocyte count \< 400 cells/μL;
10. 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;
11. 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;
12. Other conditions unsuitable for participation in this study determined by the Investigator.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Shanghai Jiaolian Drug Research and Development Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Beijing Tsinghua Changgung Hospital
Beijing, , China
Peking university first hospital
Beijing, , China
The Second Norman Bethune Hospital of Jilin University
Changchun, , China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, , China
Zhujiang Hospital of Southern Medical University
Guangzhou, , China
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, , China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
Shandong Provincial Hospital
Jinan, , China
The First Affiliated Hospital of Guangxi Medical University
Nanning, , China
Affiliated Hospital of Nantong University
Nantong, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
Northern Theater Command General Hospital
Shenyang, , China
Shengjing Hospital affiliated to China Medical University
Shenyang, , China
Peking University Shenzhen Hospital
Shenzhen, , China
Renmin Hospital of Wuhan University
Wuhan, , China
Wuxi People's Hospital
Wuxi, , China
Xi'an Daxing Hospital
Xi'an, , China
The Second Affiliated Hospital of Xingtai Medical college
Xingtai, , China
Northern Jiangsu People's Hospital
Yangzhou, , China
Yantai Yuhuangding Hospital
Yantai, , China
The First People's Hospital of Zigong
Zigong, , China
Countries
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Central Contacts
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Facility Contacts
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Yuehong Li
Role: primary
Minghui Zhao
Role: primary
Ping Luo
Role: primary
Wei Chen
Role: primary
Haibo Long
Role: primary
Hua Li
Role: primary
Heng Li
Role: primary
Rong Wang
Role: primary
Zhenhua Yang
Role: primary
Xinzhong Huang
Role: primary
Guangqun Xing
Role: primary
Yanning Zhang
Role: primary
Hua Zhou
Role: primary
Zibo Xiong
Role: primary
Dingping Yang
Role: primary
Bin Liu
Role: primary
Chengqun Zhao
Role: primary
Huixiao Zheng
Role: primary
Guangyu Bi
Role: primary
Peng Li
Role: primary
Yan Hao
Role: primary
Other Identifiers
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SPH-B007-302
Identifier Type: -
Identifier Source: org_study_id
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