Prevention of relapses with Levamisole as adjuvant therapy to corticosteroids in children with first episode of idiopathic nephrotic syndrome - LEARNS

Amsterdam University Medical Center, location AMC0 个研究点目标入组 92 人开始时间: 2019年4月16日最近更新: 2024年6月3日

试验速览

暂无简介。

•Inclusion criteria for biobanking/immunomics:
•- Children with first episode of INS aged between 2 and 16 years.
•- INS definition: Hypoalbuminaemia (albumin <25 g/L); Proteinuria (>200 mg/mmol creatinine); Complement C3 within normal range.
•- Negative pregnancy test
•- Written informed consent
•Inclusion criteria for RCT
•- 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 104
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Exclusion criteria for biobanking/immunomics:
•- Previous episodes of INS
•Exclusion criteria for RCT:
•- 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)

发起方

Amsterdam University Medical Center, location AMC