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Идёт набор NCT06781944

OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)

Фаза III С лечением Primary Membranous Nephropathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Obinutuzumab, CTX combined with Glucocorticoids.
Кому может быть актуально
Состояния в реестре: Primary Membranous Nephropathy. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicenter, Open- Label, Randomized, Clinical Trial to Investigate the Efficacy and Safety of OBINOTUZUMAB Versus Cyclophosphamide Combined With Glucocorticoids in Patients With Primary Membranous Nephropathy (Blossom Study)

Обзор

This is a randomized, parallel group, active-controlled, open-label, Phase III study comparing the efficacy and safety of obinutuzumab versus cyclophosphamide combined with glucocorticoids in patients with primary membranous nephropathy (pMN). Approximately 144 patients with pMN who have been diagnosed by biopsy or serum anti-PLA2R antibody will be enrolled. Intervention: Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26 Comparator: Cyclical cyclophosphamide and glucocorticoids Methylprednisolone 500 mg iv will be given for 3 consecutive days at the start of month 1,3,5 and followed by prednisone 0.5mg/kg/d (max 40 mg/d) for 27 days. Oral cyclophosphamide will be given for 30 days in month 2, 4, 6.

Вмешательства

  • Препарат Obinutuzumab
    Drug: Obinutuzumab Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26.
  • Препарат CTX combined with Glucocorticoids
    Drug: Glucocorticoids Methylprednisolone 500 mg iv will be given for 3 consecutive days at the start of month 1,3,5 and followed by prednisone 0.5mg/kg/d (max 40mg/d) for 27 days. Drug: CTX Oral cyclophosphamide will be given for 30 days in month 2, 4, 6.

Первичные конечные точки

  • The proportion of patients who achieve overall remission (OR) (Complete remission [CR] or prtial remission[PR]) assessed by 24-hour urinary protein to creatinine ratio at Month 24 [Срок оценки: Month 24]
Вторичные конечные точки (8)
  • The proportion of patients who achieve overall remission (OR) (Complete remission [CR] or prtial remission[PR]) assessed by 24-hour urinary protein to creatinine ratio at Month 6 [Срок оценки: Month 6]
  • The proportion of patients who achieve overall remission (OR) (Complete remission [CR] or prtial remission[PR]) assessed by 24-hour urinary protein to creatinine ratio at Month 12 [Срок оценки: Month 12]
  • The proportion of patients who achieve CR assessed by 24-hour urinary protein to creatinine ratio at Month 12 [Срок оценки: Month 12]
  • The proportion of patients who achieve PR assessed by 24-hour urinary protein to creatinine ratio at Month 12 [Срок оценки: Month 12]
  • The proportion of patients who achieve overall remission (OR) (Complete remission [CR] or artial remission[PR]) assessed by 24-hour urinary protein to creatinine ratio at Month 18 [Срок оценки: Month 18]
  • The proportion of patients who achieve CR assessed by 24-hour urinary protein to creatinine ratio at Month 18 [Срок оценки: Month 18]
  • The proportion of patients who achieve PR assessed by 24-hour urinary protein to creatinine ratio at Month 18 [Срок оценки: Month 18]
  • The proportion of patients who achieve CR assessed by 24-hour urinary protein to creatinine ratio at Month 24 [Срок оценки: Month 24]

Критерии участия

Критерии включения

  • Aged 18～75 years (including 18 and 75)old at the time of signing Informed Consent Form
  • pMN patients diagnosed according to renal biopsy (original biopsy needs to include light, immunofluorescence, and electron microscopy) within 5 years or serum anti-PLA2R antibody (≥14 RU/ml )
  • 24-hour UPCR ≥ 4 g/g and serum albumin (sALB) < 30 g/L,despite being treated with ACEi and/or ARB for ≥ 6 months prior to screening, or 24-hour UPCR ≥ 5 g/g and sALB < 30 g/L , despite being treated with ACEi and/or ARB for ≥ 3 months prior to screening; or 24-hour UPCR ≥ 8 g/g and sALB < 25 g/L, despite being treated with ACEi and/or ARB for ≥ 1 month prior to screening,.
  • eGFR ≥40 mL/min/1.73m2 (CKD-EPI), a renal biopsy is required to exclude renal damage due to other co-morbidities if eGFR <60mL/min/1.73 m2.
  • Ability to comply with the study protocol, in the investigator's judgment

Критерии исключения

  • Patients with a secondary cause of MN (e.g. hepatitis B, systemic lupus erythematosus, medications, malignancies)
  • Type 1 or 2 diabetes mellitus
  • eGFR <40 mL/min/1.73m2 (CKD-EPI) or dialysis or kidney transplantation
  • Evidence of 50% reduction in proteinuria or serum anti-PLA2R antibody within 6 months prior to screening

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 · 1 центр
  • Huashan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT06781944 · ML45515

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗