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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 81
- 主要终点
- Relapse rate at 24 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control Group
Supportive care+Prednisolone
干预措施: Supportive care+Prednisone (Drug)
Test group 1
Supportive care+Tacrolimus+Ripertamab
干预措施: Supportive care+Tacrolimus+Ripertamab (Drug)
Test group 2
Supportive care+Ripertamab
干预措施: Supportive care+Ripertamab (Drug)
结局指标
主要结局
Relapse rate at 24 months
时间窗: Up to 24 months after enrollment
Relapse: Proteinuria\>3.5g/d or PCR\>3500mg/g after complete remission has been achieved.
次要结局
- Relapse rate at 12/18 months(Up to 18 months after enrollment)
- The time from the start of treatment to achieve complete remission(Up to 24 months after enrollment)
- The time from clinical complete remission to replase(Up to 24 months after enrollment)
- Partial or complete remission at 2/6/12/24 months(Up to 24 months after enrollment)
- Safety-adverse events(The time from randomization until the occurrence of such adverse events, up to 24 months)
研究者
Shiren sun
Chief
Air Force Military Medical University, China