A Multicenter, Randomised, Double-blind Placebo-controlled Trial Assessing the Efficiency of Levamisole for Maintaining Remission After the First Flare of Steroid Sensitive Nephrotic Syndrome in Children.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Percentage of patients still in remission at 12 months after first flare of INS.
研究概览
简要总结
Idiopathic Nephrotic Syndrome is sensitive to steroid in 90% of children. However, most patients relapse and become steroid-dependant, with a long lasting relapsing course. The aim of this study is to assess the efficiency of a 6-months levamisole course, given early after first remission, on maintaining a relapse-free course at 12 months.
详细描述
Introduction (INS) is likely a primal immune disorder. Initial treatment relies on steroid therapy. NS is sensitive to steroid in more than 90% of cases, with an excellent renal prognosis. Nevertheless, 80% of patients with steroid sensitive NS do relapse, 60% within the first year. 2/3 of them will experience steroid dependency, with a long lasting relapsing course. These patients require further immunosuppressive drugs as steroid sparing agents, such as mycophenolate, cyclophosphamide, calcineurin inhibitors or rituximab. Morbidity is high and related both to the duration of the disease, sometimes until adulthood, and to treatments side effects.
Levamisole is an immunomodulator that has been used for more than thirty years in the treatment of steroid-dependent or frequently relapsing NS. Its major advantages are its immunomodulatory action and lower and reversible toxicity.
Exact physiopathology of both INS and levamisole action remain unknown. Nevertheless, we make the hypothesis that very early treatment with levamisole may enhance its efficiency and modify the disease's course.
This is the first trial to assess the efficiency of levamisole in increasing duration of remission after the first manifestation of INS.
Design :
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 24 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 24 months < age < 16 years
- •Diagnosis of first manifestation of INS defined by:
- •hypoalbuminemia < 25g/l, proteinuria > 0.20 g/mmol of urinary creatinine
- •normal C3 fraction of complement
- •Use of mechanical contraception for patients of reproductive age throughout the research period
- •Beneficiary of a social protection scheme (except AME)
- •Written informed consent from one of both parents
- •Ability to realise follow-up in full
排除标准
- •Anteriority of INS
- •Pregnancy, breast feeding or planned pregnancy during the study
- •Malignant pathology (antecedent or ongoing), diabetes, liver disease
- •Hypersensitivity to levamisole or its excipients (lactose)
研究组 & 干预措施
Levamisole Hydrochloride
Dosage : 5, 10, 25 et 50mg. Dosage form : oral tablets, coated and non dividable for taste-masking Posology : 2.5 mg/kg on alternate days maximum 150mg. Treatment duration : 6 months
干预措施: Levamisole Hydrochloride (Drug)
Placebo
matching verum
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of patients still in remission at 12 months after first flare of INS.
时间窗: 12 months
number of patients who did not relapse compared to the number of patients who had relapsed after first flare of INS.
次要结局
- Compare within levamisole and placebo groups the duration of remission.(first relapse)
- Compare within levamisole and placebo groups the frequency and level of steroid dependency(12 months)
- Compare within levamisole and placebo groups the treatment tolerance(12 months)