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Recruiting NCT06470191

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

Phase II / Phase III Interventional Primary Membranous Nephropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: B007, Cyclosporin Capsules.
Who it may be relevant to
Registry conditions: Primary Membranous Nephropathy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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

Interventions

  • Drug B007
    B007： Subcutaneous injection was administered on days 1 and 15
  • Drug Cyclosporin Capsules
    Cyclosporin Capsules： Orally, 3.5 mg/kg/d；

Primary outcome measures

  • ORR（Overall Remission Rate） [Time frame: Approximately 2 years]
Secondary outcome measures (3)
  • CRR（Complete Remission Rate） [Time frame: Approximately 2 years]
  • PRR（Partial Remission Rate） [Time frame: Approximately 2 years]
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: Approximately 2 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 21 centers
  • Beijing Tsinghua Changgung Hospital — Beijing
  • Peking university first hospital — Beijing
  • The Second Norman Bethune Hospital of Jilin University — Changchun
  • The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
  • Zhujiang Hospital of Southern Medical University — Guangzhou
  • Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine — Hangzhou
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
  • Shandong Provincial Hospital — Jinan
  • … and 13 more centers

Identifiers

NCT: NCT06470191 · SPH-B007-302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗