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RECRUITINGPHASE2/PHASE3

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.

NCT06470191•Shanghai Jiaolian Drug Research and Development Co., Ltd

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Summary

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

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

Key Dates

Start Date

July 30, 2024

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

March 25, 2025

Enrollment

216

ESTIMATED participants

Conditions

Primary Membranous Nephropathy

Interventions

B007

DRUG

Cyclosporin Capsules

DRUG

Contacts

Minghui Zhao

CONTACT

0086- 010-66119025 bdyyec@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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