A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.
- Conditions
- Primary Membranous Nephropathy
- Interventions
- Registration Number
- NCT06470191
- Lead Sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd
- Brief Summary
To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 216
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B007 B007 - Cyclosporin Capsules Cyclosporin Capsules -
- Primary Outcome Measures
Name Time Method ORR（Overall Remission Rate） Approximately 2 years
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Approximately 2 years PRR（Partial Remission Rate） Approximately 2 years CRR（Complete Remission Rate） Approximately 2 years
Trial Locations
- Locations (21)
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, 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
Peking university first hospital
🇨🇳Beijing, China
The Second Norman Bethune Hospital of Jilin University
🇨🇳Chang chun, 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