Study of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome

Официальное название

Study of Different Doses of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome：An Open-label Randomized Controlled Trial

Обзор

This is an open-label randomized controlled trial to evaluate the efficacy and safety of one dose versus two doses of ripertamab in children with frequent relapses or steroid-dependent nephrotic syndrome (FRNS/SDNS).

Вмешательства

• Препарат ripertamab
  2 doses of 375mg/m2 BSA ripertamab at 1-week intervals( within ±1days). At the meantime, prednisone is administered at a dose of 1.5 mg/kg/d (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg/kg every 2 weeks, and the drug is discontinued at 3 months.
• Препарат ripertamab
  1 dose of 375mg/m2 BSA ripertamab. At the meantime, prednisone is administered at a dose of 1.5 mg/kg/d (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg/kg every 2 weeks, and the drug is discontinued at 3 months.

Первичные конечные точки

• Relapse free survival rate [Срок оценки: 1 year]

Вторичные конечные точки (5)

• Recurrence frequency at 6 and 12 months [Срок оценки: 1 year]
• Cumulative corticosteroid dose [Срок оценки: 1 year]
• Median recurrence-free survival [Срок оценки: 18 months]
• B-cell count [Срок оценки: 18 months]
• The occurrence and severity of adverse events [Срок оценки: 18 months]

Критерии участия

Критерии включения

• 16 years old and above with FRNS/SDNS
• Before enrollment, achieved complete remission (urine protein/creatinine ratio (morning urine or 24-hour urine) ≤ 20mg/mmol (0.2mg/mg) or < 100mg/m2/d, or test strip result negative or trace)
• Within 2 months before enrollment, did not use levamisole, alkylating agents such as cyclophosphamide, calcineurin inhibitors such as cyclophosphamide and cyclosporine, or mycophenolate mofetil. Within 6 months before enrollment, did not use other CD20 monoclonal antibodies (such as ofatumumab, otuzumab, etc., excluding rituximab)
• Glomerular filtration rate (eGFR) > 60ml/min/1.73m2
• The patient or their guardian agrees to participate in this clinical trial and signs the informed consent form, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the study

Критерии исключения

• Known causes (such as systemic lupus erythematosus, IgA nephropathy, other secondary nephrotic syndromes, amyloidosis, malignant tumors, etc.)
• Known active chronic infections, including tuberculosis, HIV, HBV, HCV, etc.
• Severe leukopenia (white blood cells < 3.0×109/L), severe anemia (hemoglobin < 8.9 g/dl), thrombocytopenia (platelets < 100×109/L), or liver dysfunction (alanine aminotransferase/aspartate aminotransferase > 2 times the upper limit of normal)
• Received live vaccines within 1 month prior to screening
• Currently participating in other drug clinical trials
• Other conditions that the investigator deems make the patient unsuitable for this study

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

• Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province 3 — Ханчжоу

Идентификаторы

NCT: NCT07388810 · SCT400-NS-ch

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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