EUCTR2014-001991-76-DE进行中（未招募）1 期
Initial treatment of idiopathic nephrotic syndrome in children with mycophenolate mofetil vs. prednisone: A randomized, controlled, multicenter study - INTENT
Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial0 个研究点目标入组 340 人开始时间: 2014年10月30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
- 340
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
- •Subjects meeting all of the following criteria will be considered for admission to the study:
- •-First episode of steroid-sensitive nephrotic syndrome (SSNS)
- •-in remission induced by daily glucocorticoids
- •-male and female children aged = 1 year and = 10 years at beginning of study (typical age range of patients with SSNS
- •-Ability of the persons having care and custody of the child to understand character and individual consequences of clinical study
- •-Written informed consent of the persons having care and custody of the child (must be available before enrolment in the study)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 340
- •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
- •Subjects presenting with any of the following criteria will not be included in the study:
- •-Secondary nephrotic syndrome
- •-estimated glomerular filtration rate (eGFR) <90 ml/min x 1.73 m2 BSA
- •-Ongoing treatment with systematically administered glucocorticoids or other immunosuppressive drugs at time of first episode of nephrotic syndrome.
- •Hemoglobin concentration of =9 g/dL
- •Leucocyte count of =2.500/µl
- •Refusal of subject (please see also chapter 10.5)•
- •Severe chronic gastrointestinal disease
- •-History of hypersensitivity to mycophenolate mofetil or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of suspension of mycophenolate mofetil (CellCept suspension?)
- •-Participation in other clinical studies or observation period of competing studies, respectively.
研究者
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