A Real-world Study to Evaluate the Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,507
- 试验地点
- 17
- 主要终点
- Duration of positive urine protein test changing to the negative result
研究概览
简要总结
This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome.
详细描述
This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome(PNS). The study will be Planned at 1500 participants, and subjects will be on study for up to one year. Data will be collected by authorized physicians for 48 weeks. all of the data included demographic characteristics, information about PNS, laboratory tests and adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In accordance with Pediatric Branch , the Chinese Medical Association in 2009: guidelines for diagnosis and treatment of common kidney diseases in children (for trial)Ⅰ. Hormone-sensitive, relapsed/dependent nephrotic syndrome diagnostic and evidence-based guidelines; Ⅲ.Diagnostic criteria for the diagnostic and evidence-based guidelines for hormone-resistant nephrotic syndrome, which means children who are diagnosed with primary nephrotic syndrome should be included;
- •Age from 1 to18;
- •ALT and AST levels do not exceed twice the upper limit of the normal range;;
- •Provision of written informed consent by legal guardians.
排除标准
- •a variety of secondary nephrotic syndromes are caused by infectious diseases such as lupus nephritis, hepatitis b associated nephritis, purpura nephritis, and EB virus, cytomegalovirus (CMV), etc;
- •with combined diseases of cardiovascular, liver, hematopoietic system, mental disorders and other serious diseases;
- •History of diabetes or examinations showed elevated blood glucose levels;
- •Participation in other ongoing clinical trials or during their observation period within the last three months prior to visit 1;
- •Previous/concomitant treatment with any other immunomodulators within the last three months prior to visit 1 ;
- •Patients who are unlikely to adhere to the protocol.
结局指标
主要结局
Duration of positive urine protein test changing to the negative result
时间窗: 48 weeks after treatment
Duration of positive urine protein test changing to the negative result was measured from day 1 until the time of positive urine protein test changing to negative, assessed up to 48 weeks.
The decrease of 24-hour urine protein level
时间窗: 48 Weeks after treatment
Compared 24-hour urine protein level between baseline and follow-up timepoint, measured from day 1 until time of positive urine protein test changing to negative, assessed up to 48 weeks.
The ratio of positive to negative urine protein
时间窗: 48 Weeks after treatment
The proportion of negative urine protein subjects to the total number of subjects, measured from day 1 until the time of positive urine protein test changing to negative, assessed up to 48 weeks.
次要结局
- Recurrence rate of PNS(48 Weeks after treatment)
- Recovery of blood albumin levels(48 Weeks after treatment)
- Rates of infectious complications of PNS(48 Weeks after treatment)