A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.

Last updated: March 24, 2025
Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Overall Status: Active - Recruiting

Phase

2/3

Condition

Idiopathic Membranous Nephropathy

Nephrotic Syndrome

Glomerulonephritis

Treatment

B007

Cyclosporin Capsules

Clinical Study ID

NCT06470191
SPH-B007-302
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects with primary membranous nephropathy pathologically confirmed by renalbiopsy;

  2. Subjects with glomerular filtration rate(eGFR) ≥ 45 mL/min/1.73 m2.

  3. If taking Angiotensin converting enzyme inhibitors/angiotensin II receptorantagonists/sodium-glucose cotransporter 2 inhibitors/endothelin inhibitors, astable dose within 4 weeks before randomization;

  4. Subjects with 24-hour elevated urinary protein in accordance with the prescribedconditions;

  5. Subjects whose laboratory test results meet the prescribed standards during thescreening period;

  6. Subjects who have fully understood this study and voluntarily signed the informedconsent form;

  7. Subjects who are able to follow the study protocol as judged by the investigator.

Exclusion

Exclusion Criteria:

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

  2. Subjects identified by the investigator as previously resistant to CD20 monoclonalantibody 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 monoclonalantibodies, or known allergies to any component of cyclosporine or B007;

  6. Subjects who received live vaccination, major surgery, or participated in otherclinical trials within 28 days before receiving the study drug;

  7. Subjects with positive hepatitis B surface antigen; those with positive hepatitis Cvirus antibody; those with a history of immunodeficiency or suffer from otheracquired or congenital immunodeficiency diseases;

  8. Subjects who have a clear history of tuberculosis or have received anti-tuberculosistreatment;

  9. Subjects with CD4+ T lymphocyte count < 400 cells/μL;

  10. Pregnant or lactating women; women of childbearing potential who have not beensterilized do not agree to use appropriate contraceptive measures during treatmentand 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 useof barrier contraception during the study period and for at least 12 months afterthe last administration of the study drug, and who do not consent to the use ofother contraceptive methods by their spouses;

  12. Other conditions unsuitable for participation in this study determined by theInvestigator.

Study Design

Total Participants: 216
Treatment Group(s): 2
Primary Treatment: B007
Phase: 2/3
Study Start date:
July 30, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Beijing Tsinghua Changgung Hospital

    Beijing,
    China

    Active - Recruiting

  • Peking university first hospital

    Beijing,
    China

    Active - Recruiting

  • The Second Norman Bethune Hospital of Jilin University

    Chang chun,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian,
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou,
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou,
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine

    Hangzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou,
    China

    Active - Recruiting

  • Shandong Provincial Hospital

    Jinan,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning,
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong,
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao,
    China

    Active - Recruiting

  • Northern Theater Command General Hospital

    Shenyang,
    China

    Active - Recruiting

  • Shengjing Hospital affiliated to China Medical University

    Shenyang,
    China

    Active - Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen,
    China

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan,
    China

    Active - Recruiting

  • Wuxi People's Hospital

    Wuxi,
    China

    Active - Recruiting

  • Xi'an Daxing Hospital

    Xi'an,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Xingtai Medical college

    Xingtai,
    China

    Active - Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou,
    China

    Active - Recruiting

  • Yantai Yuhuangding Hospital

    Yantai,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Site Not Available

  • The First People's Hospital of Zigong

    Zigong,
    China

    Active - Recruiting

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