JPRN-UMIN000014347已完成3 期
Mycophenolate mofetil for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind, randomised, placebo-controlled trial(JSKDC07) - Mycophenolate mofetil for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind, randomised, placebo-controlled trial(JSKDC07)
Japanese Study Group of Kidney Disease in Children0 个研究点目标入组 80 人开始时间: 2014年6月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 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
- 2years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.Patients who have been diagnosed with nephritic-NS, such as IgA nephropathy prior to assignment or in whom secondary NS is suspected. 2.Patients meeting either one of the following infection: 1) Presence or history of severe infections within 6 months prior to assignment. 2) Presence or history of opportunistic infections within 6 months prior to assignment. 3) Presence of active tuberculosis. 4) Patients with a history of tuberculosis or in whom tuberculosis is suspected. 5) Presence or history of active Hepatitis B or Hepatitis C or hepatitis B virus carrier. 6) Presence of HIV infection. 3.Presence or history of angina pectoris, cardiac failure, myocardial infarction, or serious arrhythmia (findings observed under Grade 4 of the CTCAE v4.0-JCOG. 4.Presence or history of auto-immune diseases or vascular purpura. 5.Presence or history of malignant tumor. 6.History of organ transplantation. 7.History of drug allergies to methylprednisolone, acetaminophen, or d-chlorpheniramine maleate. 8.Uncontrollable hypertension. 9.Deteriorated kidney function, e.g. estimated GFR<60 mL/min./1.73m2. 10.Having received a live vaccine within 4 weeks prior to enrollment. 11.Patients showing either one of the following abnormal clinical laboratory value: 1)WBC <3,000/microL. 2)neutrophil <1,500/microL. 3)PLT <50,000/microL. 4)ALT >2.5 x upper limit of normal value. 5)AST >2.5 x upper limit of normal value. 6)Positive for HBs antigen, HBs antibody, HBc antibody and HCV antibody. 7)Positive for HIV antibody. 12.Patients who do not agree with contraception during the study period. 13.Women during pregnancy or breast-feeding. 14.Judged inap.propriate for this study by the physicians.
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