NL-OMON47536招募中不适用
Double-blind, randomized, placebo controlled study to REduce STEroids in Relapsing Nephrotic syndrome - RESTERN Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
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.
排除标准
- •- Steroid resistant nephrotic syndrome;
- •- Daily prednisone maintenance therapy at any dose;
- •- Alternate day prednisone maintenance therapy at a dose over 4 mg/m2;
- •- Documented or suspected significant non-compliance.
- •- Pregnancy;
- •- Stimulant drug use;
- •- Comorbidity;
- •o Kidney transplant recipient
- •o Any 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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