Treatment of Primary Membranous Nephropathy with B007

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.

This study is testing a new treatment called B007, along with cyclosporin, to see if it can improve kidney function and reduce protein levels in people with primary membranous nephropathy.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd (industry)
• Locations: 21 sites (Beijing and 20 other locations)
• Trial ID: NCT06470191 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the efficacy and safety of B007 in treating patients with primary membranous nephropathy. It involves administering B007 alongside cyclosporin capsules to assess improvements in kidney function and reduction in proteinuria. The study is designed for patients with confirmed primary membranous nephropathy and aims to determine the optimal treatment approach through a phased methodology.

Who should consider this trial

Good fit: Ideal candidates are adults with pathologically confirmed primary membranous nephropathy and a glomerular filtration rate of at least 45 mL/min.

Not a fit: Patients with secondary membranous nephropathy or those with specific pathological findings indicating concomitant crescent bodies may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and quality of life for patients with primary membranous nephropathy.

How similar studies have performed: Other studies have shown promise in treating primary membranous nephropathy with similar therapeutic approaches, suggesting potential for success.

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.

Where this trial is running

Beijing and 20 other locations

• Beijing Tsinghua Changgung Hospital — Beijing, China (RECRUITING)
• Peking university first hospital — Beijing, China (RECRUITING)
• The Second Norman Bethune Hospital of Jilin University — Changchun, China (RECRUITING)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, China (RECRUITING)
• Zhujiang Hospital of Southern Medical University — Guangzhou, China (RECRUITING)
• Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine — Hangzhou, China (RECRUITING)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China (RECRUITING)
• Shandong Provincial Hospital — Jinan, China (RECRUITING)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, China (RECRUITING)
• Affiliated Hospital of Nantong University — Nantong, China (RECRUITING)
• The Affiliated Hospital of Qingdao University — Qingdao, China (RECRUITING)
• Northern Theater Command General Hospital — Shenyang, China (RECRUITING)
• Shengjing Hospital affiliated to China Medical University — Shenyang, China (RECRUITING)
• Peking University Shenzhen Hospital — Shenzhen, China (RECRUITING)
• Renmin Hospital of Wuhan University — Wuhan, China (RECRUITING)
• Wuxi People's Hospital — Wuxi, China (RECRUITING)
• Xi'an Daxing Hospital — Xi'an, China (RECRUITING)
• The Second Affiliated Hospital of Xingtai Medical college — Xingtai, China (RECRUITING)
• Northern Jiangsu People's Hospital — Yangzhou, China (RECRUITING)
• Yantai Yuhuangding Hospital — Yantai, China (RECRUITING)
• The First People's Hospital of Zigong — Zigong, China (RECRUITING)

Study contacts

• Study coordinator: Minghui Zhao

Conditions: Primary Membranous Nephropathy