Clinical trial NCT06470191: A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Primary Membranous Nephropathy
Lead sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Pharmaceuticals Holding Co., Ltd
First posted: 2024-06-24
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy


Eligibility criteria: Inclusion Criteria:

1. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
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:

1. Subjects with secondary membranous nephropathy or primary membranous nephropathy whose pathological reports suggest concomitant crescent bodies;
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.

Primary outcomes:
measure: ORR（Overall Remission Rate）
timeFrame: Approximately 2 years
Secondary outcomes:
measure: CRR（Complete Remission Rate）
timeFrame: Approximately 2 years
measure: PRR（Partial Remission Rate）
timeFrame: Approximately 2 years
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Beijing
country: China
facility: Peking university first hospital
city: Chang chun
country: China
facility: The Second Norman Bethune Hospital of Jilin University
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shenyang
country: China
facility: Northern Theater Command General Hospital
city: Shenyang
country: China
facility: Shengjing Hospital affiliated to China Medical University
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Xi'an
country: China
facility: Xi'an Daxing Hospital
city: Xingtai
country: China
facility: The Second Affiliated Hospital of Xingtai Medical college
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zigong
country: China
facility: The First People's Hospital of Zigong
Study officials:
References: