EUCTR2016-002430-76-BE进行中（未招募）1 期
Double-blind, randomized, placebo controlled noninferiority intervention study to REduce STEroids in Relapsing Nephrotic syndrome - the RESTERN study
Radboudumc, Amalia Children’s Hospital, Department of Pediatrics0 个研究点目标入组 144 人开始时间: 2017年11月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age over 1 and less than 18 years;
- •Steroid sensitive nephrotic syndrome;
- •The last prednisolone use (at a dose over 10 mg/m2 on alternate days) for the treatment of a previous episode was at least 4 weeks ago;
- •Signed informed consent from the parent or legal assent and/or the patient, depending on the age of the patient.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 144
- •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
排除标准
- •Steroid resistant nephrotic syndrome;
- •Daily prednisolone maintenance therapy at any dose;
- •Alternate day prednisolone maintenance therapy at a dose over 4 mg/m2;
- •Documented or suspected significant non-compliance;
- •Pregnancy;
- •Stimulant drug use;
- •Comorbidity;
- •oKidney transplant recipient;
- •oAny disease that requires the variation in oral prednisolone to be at the discretion of the treating physician(s);
- •Concomitant use of drugs that induce CYP 3A4: carbamazepine, phenobarbital, phenytoin and/or rifampicin;
- •Concomitant use of drugs that inhibit CYP 3A4: ketaconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics (erythromycin), diltiazem, verapamil.
研究者
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