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

Официальное название

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.

Обзор

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

Вмешательства

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

Первичные конечные точки

• ORR（Overall Remission Rate） [Срок оценки: Approximately 2 years]

Вторичные конечные точки (3)

• CRR（Complete Remission Rate） [Срок оценки: Approximately 2 years]
• PRR（Partial Remission Rate） [Срок оценки: Approximately 2 years]
• Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: Approximately 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 21 центр

• Beijing Tsinghua Changgung Hospital — Пекин
• Peking university first hospital — Пекин
• The Second Norman Bethune Hospital of Jilin University — Changchun
• The First Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
• Zhujiang Hospital of Southern Medical University — Гуанчжоу
• Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine — Ханчжоу
• The First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу
• Shandong Provincial Hospital — Цзинань
• … и ещё 13 центров

Идентификаторы

NCT: NCT06470191 · SPH-B007-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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