INSIGHT (Insight Into Nephrotic Syndrome: Investigating Genes, Health and Therapeutics)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Relapse (number of relapses)
研究概览
简要总结
INSIGHT is a longitudinal study of childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression.
详细描述
INSIGHT is a longitudinal observational study of childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression. This is a large multiethnic cohort to test hypotheses of gene and environmental risk factors and disease progression. Participants are recruited from Toronto, Ontario and surrounding regions. Additional sites will be added on in the future.
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
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of nephrotic syndrome
- •signed informed consent and assent appropriate for age
- •ages 6 months -18 years old and
- •ability to complete questionnaires
排除标准
- •congenital nephrotic syndrome (less than age 1)
- •syndromic disease with multiple organ involvement
- •inability to provide consent by primary care providers
- •conditions such as systemic lupus erythematous.
结局指标
主要结局
Relapse (number of relapses)
时间窗: Entire follow-up
After remission, an increase in the first AM morning urine protein ≥ 3+ for 3 consecutive days or increase in maintenance prednisone dose
次要结局
- Frequently relapsing NS (yes or no)(6, 12, 18 and 24 months)
- Steroid - dependent NS (yes or no)(6, 12, 18 and 24 months)
- Initial Steroid Resistance (yes or no)(Up to 16 weeks)
- CKD (yes or no)(Entire follow-up)
- ESRD (yes or no)(Entire follow-up)
研究者
Rulan Parekh
Staff Physician
The Hospital for Sick Children