RecruitingPhase 2Phase 3NCT06470191

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

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.


Sponsor

Shanghai Jiaolian Drug Research and Development Co., Ltd

Enrollment

216 participants

Start Date

Jul 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • 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.

Exclusion Criteria12

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGB007

B007: Subcutaneous injection was administered on days 1 and 15

DRUGCyclosporin Capsules

Cyclosporin Capsules: Orally, 3.5 mg/kg/d;


Locations(21)

Beijing Tsinghua Changgung Hospital

Beijing, China

Peking university first hospital

Beijing, China

The Second Norman Bethune Hospital of Jilin University

Changchun, 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

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06470191


Related Trials