2024-517467-23-00招募中3 期
Prevention of relapse with Levamisole as adjuvant therapy to corticosteroids in children with first episode of idiopathic nephrotic syndrome
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 87
- 试验地点
- 13
- 主要终点
- The occurrence of relapses within 12 months after first presentation. A relapse is defined as the recurrence of proteinuria (3+ urine dipstick or proteinuria> 200 mg/mmol creatinine) for 3 consecutive days
研究概览
简要总结
To investigate the effect of additional levamisole in comparison with placebo from 4 weeks to 6 months after the start of the first episode of steroid-sensitive INS in children (age 2 – 16 years) on the occurrence of relapses within 12 months.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Steroid-sensitive INS (Remission after 4 weeks of corticosteroid treatment)
- •Weight >9 kg
- •Ability to swallow a (placebo) tablet of 5 mg (successful swallowing test in children <6 years)
- •Negative pregnancy test in girls that are of childbearing potential
- •Absence of contraindication for levamisole use: neutropenia <1500/mmP3
- •Written informed consent
- •Ability to comply with study protocol
排除标准
- •Steroid-resistant INS (persistent proteinuria at 4 weeks after start steroid treatment).
- •Previous or current malignancy, diabetes mellitus, current liver disease, or convulsions.
- •Hypersensitivity to levamisole or one of its substances (lactose)
结局指标
主要结局
The occurrence of relapses within 12 months after first presentation. A relapse is defined as the recurrence of proteinuria (3+ urine dipstick or proteinuria> 200 mg/mmol creatinine) for 3 consecutive days
The occurrence of relapses within 12 months after first presentation. A relapse is defined as the recurrence of proteinuria (3+ urine dipstick or proteinuria> 200 mg/mmol creatinine) for 3 consecutive days
次要结局
- Time to first relapse
- Relapse rate (number of relapses per person year) over 2-year period
- Cumulative steroid dosage up to 2 years
- Occurrence of adverse events and treatment discontinuation
- Proportion of frequent relapsers or steroid dependency over 2-year period
- Toxicity of levamisole: Proportion of patients with elevated ASAT- /ALAT-levels (>3 times upper limit of normal), neutropenia (<1500/mm3) or positive ANCA.
- Toxicity of corticosteroids: Differences in BMI, blood pressure, height, weight, serum glucose between groups; Proportion of patients with overweight (BMI >25 kg/m2, hypertension (p>90), and hyperglycemia
- Days of school missing, outpatient visits and hospitalization days (macro-economic analysis)
- Number of treatment interruptions
研究者
Dr. A.H. Bouts
Scientific
Amsterdam UMC Stichting
研究点 (13)
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