Efficacy and Safety of Tacrolimus in Combination With Ripertamab in the Initial Treatment of Patients With MCD

Официальное название

Efficacy and Safety of Tacrolimus in Combination With Anti-CD20 Monoclonal Antibody (Ripertamab) in the Initial Treatment of Patients With Minimal Change Disease: a Multi-center Randomized Controlled Clinical Trial

Обзор

To evaluate the safety and efficacy of ripertamab and its combination with tacrolimus in the initial treatment of MCD to provide a treatment regimen with higher remission rates, lower recurrence rates, and fewer side effects in patients with MCD.

Подробное описание

Minimal change disease is the third most common primary kidney disease in adults with idiopathic nephrotic syndrome. The pathological features of the disease are no or only slight changes under light microscope, and the foot process fusion under electron microscope. The KDIGO guidelines recommend oral adequate doses of glucocorticoids as the initial treatment for adults with MCD. However, 48%-76% of patients relapse after tapering or gradual discontinuation of the drug, requiring a high cumulative dose of glucocorticoids. As the cumulative dose of glucocorticoids increases, the potential for side effects increases. In addition, 10% to 30% of patients frequently relapse, and 15% to 30% of these are steroid dependent. Therefore, the clinical goals for patients with MCD are to achieve early remission of proteinuria, reduce hormonal side effects, and more importantly, prevent the recurrence of proteinuria.

Вмешательства

• Препарат Supportive care+Prednisone
  Supportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise. Induction period: 1mg/kg/day. The maximum dose is not more than 60mg. The duration of adequate prednisone is a minimum of 4 weeks and a maximum of 16 weeks. Maintenance period: A reduction of 5-10mg/wk was initiated after 2 weeks of complete remission and finally discontinued after 6 months of maintenance at 5mg/day.
• Препарат Supportive care+Tacrolimus+Ripertamab
  Supportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise. Tacrolimus：Induction period: 0.05mg/kg/d. It will be given in two doses 12 hours apart. The blood concentration should be up to 5-10ng/ml. Maintenance therapy was initiated two weeks after complete remission; Maintenance period: Reduced to a blood concentration of 3-8ng/ml, and stopped after 6 months of maintenance treatment. Ripertamab: Given twice every two weeks at a dose of
• Препарат Supportive care+Ripertamab
  Supportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise. Ripertamab: Given twice every two weeks at a dose of 1000mg. 1000mg is added at 6 months.

Первичные конечные точки

• Relapse rate at 24 months [Срок оценки: Up to 24 months after enrollment]

Вторичные конечные точки (5)

• Relapse rate at 12/18 months [Срок оценки: Up to 18 months after enrollment]
• Partial or complete remission at 2/6/12/24 months [Срок оценки: Up to 24 months after enrollment]
• The time from the start of treatment to achieve complete remission [Срок оценки: Up to 24 months after enrollment]
• The time from clinical complete remission to replase [Срок оценки: Up to 24 months after enrollment]
• Safety-adverse events [Срок оценки: The time from randomization until the occurrence of such adverse events, up to 24 months]

Критерии участия

Критерии включения

• Age 18-80 years old;
• Primary minimal change disease confirmed by renal biopsy (Initial therapy);
• 24h-UTP>3.5g/d or PCR>3500mg/g, and serum albumin<30g/L;
• Agree to participate in the project and sign the informed consent.

Критерии исключения

• Secondary minimal change disease;
• eGFR<60 mL/min/1.73m2;
• Had history of mental disease, dysnoesia, serious cardiovascular and cerebrovascular diseases, pulmonary insufficiency, malignant tumors or other major diseases that are not suitable for clinical experiments;
• Active bleeding in the gastrointestinal tract;
• Prior treatment with corticosteroids or other immunosuppressants;
• HBV, HCV, HIV or other untreated infections, congenital or acquired immunodeficiency diseases;
• Have been vaccinated with live vaccine in the past four weeks;
• Serum bilirubin > 3.6mg/dl for at least 1 month or liver function ≥3 times the upper limit of normal value;
• Allergic to prednisolone, tacrolimus, or ripertamab;
• Reluctance to use contraception or plan pregnancy/lactation within 6 months of study completion;
• Had history of alcohol/drug abuse;
• Unable to give informed consent.

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: NCT06405100 · TAC and ripertamab in MCD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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