Treatment of Primary Membranous Nephropathy with B007

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Minghui Zhao
• Email: bdyyec@163.com
• Phone: 0086- 010-66119025

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Surovatamig for adults with anti‑PLA2R primary membranous nephropathy

  This study will test whether subcutaneous surovatamig is safe and can reduce heavy proteinuria in adults with anti‑PLA2R–positive primary membranous nephropathy.

  Recruiting Phase 2 AstraZeneca · Los Angeles, California and 26 other locations · NCT07571746

• SHR-2173 injections for adults with primary membranous nephropathy

  This Phase II test will try SHR-2173 injections in adults (18–75) with biopsy-proven primary membranous nephropathy to see if they are safe, reduce disease activity, and to measure how the drug acts in the body.

  Recruiting Phase 2 Guangdong Hengrui Pharmaceutical Co., Ltd · Nanjing, Jiangsu · NCT07289763

• Povetacicept for people with primary membranous nephropathy

  This trial tests whether povetacicept is safe and helps people with primary membranous nephropathy, with tacrolimus listed as an intervention in the protocol.

  Recruiting at 116 sites Phase 2/3 Vertex Pharmaceuticals Incorporated · Montgomery, Alabama and 116 other locations · NCT07204275

• ALXN1920 for adults with primary membranous nephropathy

  This trial will test whether ALXN1920 reduces urine protein in adults with primary membranous nephropathy who are at high risk of progression compared with placebo.

  Recruiting at 35 sites Phase 2 Alexion Pharmaceuticals, Inc. · Loma Linda, California and 39 other locations · NCT07157787

• Budoprutug for primary membranous nephropathy (Phase 2)

  This trial will test whether budoprutug, an anti-CD19 antibody given by IV, is safe and tolerated and may reduce proteinuria in adults with PLA2R-positive primary membranous nephropathy who still have high protein in their urine despite RAAS blockers.

  Recruiting at 35 sites Phase 2 Climb Bio, Inc. · Denver, Colorado and 37 other locations · NCT07096843

• Evaluating YK012 for treating primary membranous nephropathy

  This study is testing a new treatment called YK012 to see if it can help people with primary membranous nephropathy feel better and how safe it is to use.

  Recruiting Phase 1 Excyte Biopharma Ltd · Beijing, Beijing Municipality · NCT06982729

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.