The Canadian Childhood Nephrotic Syndrome (CHILDNEPH) Project
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 12
- 主要终点
- Association of steroid dose prescribed with relapse rates
研究概览
简要总结
CHILDNEPH is a pan-Canadian project to observe clinical care for children with nephrotic syndrome. Previous studies have indicated that there is wide practice variation in how health care providers treat this remitting and relapsing disease of childhood. The disease mechanism is not yet understood, and long-term use of steroids can affect children's health. This study involves assessment of routine clinical care and establishing a long-term patient registry for children with nephrotic syndrome.
详细描述
CHILDNEPH is an ongoing prospective longitudinal study of children with incident and prevalent nephrotic syndrome. Children are recruited from 12 centres across Canada and followed for at least 30 months. The project starting in August of 2013 with the goal of following 400 patients. Data is collected at enrollment, beginning and end of each relapse, semi-annual visits and end of study. Detailed prescription data is collected regarding glucocorticoids and all second line agents. All relapses are recorded with time to urinary remission of proteinuria.
The investigators are moving towards registry based trials to determine optimal treatment protocols for nephrotic syndrome with an overall goal to minimize glucocorticoid exposure, a patient priority.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis with Nephrotic Sydrome at initial presentation, first or second relapse
排除标准
- •unable to participate in English or French
- •Nephrotic Syndrome is secondary to other disease
- •Younger than one year old or older than 17 years
结局指标
主要结局
Association of steroid dose prescribed with relapse rates
时间窗: 30 months up to 90 months
Total steroid dose prescribed per unit time is determined by the total dose patients are prescribed during observation divided by total number of days on treatment. Dose will always be in mg/m2 prednisone equivalents. The relapse rate is the number of relapses/per person unit time.
次要结局
未报告次要终点