A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.
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.
1 other identifier
interventional
216
1 country
21
Brief Summary
To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2024
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
June 24, 2024
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 5, 2026
April 1, 2026
2.4 years
June 17, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
ORR（Overall Remission Rate）
Approximately 2 years
Secondary Outcomes (3)
CRR（Complete Remission Rate）
Approximately 2 years
PRR（Partial Remission Rate）
Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Approximately 2 years
Study Arms (2)
B007
EXPERIMENTALCyclosporin Capsules
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2024
First Posted
June 24, 2024
Study Start
July 30, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04