Rituximab Combining With Low-Dose Mycophenolate Mofetil on Proliferative Lupus Nephritis in Children

Официальное название

Efficacy and Safety of Rituximab Combining With Low-Dose Mycophenolate Mofetil in the Induction Therapy of Proliferative Lupus Nephritis in Children

Обзор

The objective of this study is to assess the efficacy and safety of rituximab combining with low-dose mycophenolate mofetil in the induction therapy of proliferative lupus nephritis in children.

Вмешательства

• Препарат rituximab
  Rituximab is given monthly (375m/m2；maximum 500mg) for 6 doses
• Препарат Mycophenolate Mofetil (MMF) Treatment
  The dose of mycophenolate mofetil is 10 to 15mg/kg/d for 6 months.
• Препарат Cyclophosphamide
  The therapy for cyclophosphamide is 750mg/m2（maximum 1000mg） every month for 6 doses.
• Препарат ACEI / ARB
  ACEI/ARB is recommended as the basic therapy for lupus nephritis.
• Препарат Corticosteroid
  Corticosteroid is recommended as the basic therapy for lupus nephritis.
• Препарат Hydroxychloroquine (HCQ)
  Hydroxychloroquine is recommended as the basic therapy for lupus nephritis.

Первичные конечные точки

• Complete response [Срок оценки: 6 months after the intervention]
• Partial response [Срок оценки: 6 months after the intervention]
• No kidney response [Срок оценки: 6 months after the intervention]

Вторичные конечные точки (1)

• SLEDAI scores [Срок оценки: 6 months after the intervention]

Критерии участия

Критерии включения

• Children aged 3-18 years old, regardless of sex;
• SLE patients who meet the 2019 EULAR/ACR SLE criteria or the 2012 SLICC diagnostic criteria;
• Diagnosed as lupus nephritis and the classification was consistent with proliferative lupus nephritis (type III or IV, with or without type V);
• White blood cell count ≥3.0×10\^9/L, and lymphocyte count ≥ 0.5× 10\^9/L and CD20 (or CD19)≥1/ul;
• No cyclophosphamide or rituximab induction therapy was used before enrollment;
• Informed consent form is signed by the guardian and children over 8 years old;
• In the active stage of the disease, the 24-hour urine protein quantification ≥25mg/kg, or the urine protein/creatinine ≥1.0mg/mg;
• Estimated GFR≥60ml/min/1.73m\^2 (improved Swchartz formula).

Критерии исключения

• Patients with lupus encephalopathy;
• Estimated GFR<60ml/min/1.73m\^2(Swchartz formula);
• HBV-antigen positive, HCV or HIV antibody positive;
• Severe infection (including chronic hepatitis, EB virus or cytomegalovirus infection) and tuberculosis;
• Allergic to the active ingredients or any auxiliary materials in rituximab, mycophenolate mofetil or cyclophosphamide;
• Severe heart failure and liver function damage;
• Patients who is not suitable to participate in this study judged by the researchers.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07675291 · NEFC-2025-711

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗