Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 5
- 主要终点
- kidney volume
研究概览
简要总结
The Division of Kidney Urology and Hematology Disease (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funded a cooperative agreement (UO1) for a consortium of participating clinical centers (PCCs) and a data coordinating and imaging analysis center (DCIAC) to develop and implement studies to test whether imaging techniques can provide accurate and reproducible markers of progression of renal disease in patients with polycystic kidney disease.
The awarded participating clinical centers are Emory University, University of Kansas, and Mayo Foundation (with a subcontract to the University of Alabama). The awarded DCIAC is Washington University in St. Louis. Due to the relocation of the DCIAC P.I. from Washington University to the University of Pittsburgh, the DCIAC for CRISP II is located at the University of Pittsburgh.
详细描述
The goal of the CRISP Study is to conduct a prospective, longitudinal trial to evaluate the accuracy and validity of magnetic resonance imaging to determine disease progression in ADPKD defined as a change in both renal and renal cyst volumes and renal function over time.
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
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CRISP I participants will be invited to participate in CRISP II. At entry into CRISP I participants met a number of inclusion and exclusion criteria.
排除标准
- •Current psychiatric or addiction or non-compliance disorder that in the discretion of the principal investigator indicates that the subject will not successfully complete the study;
- •Current medical problem that in the discretion of the principal investigator would make unsafe the participation in the study;
- •Inability to provide written informed consent
结局指标
主要结局
kidney volume
时间窗: three years
次要结局
未报告次要终点
研究者
Kyongtae Ty Bae, M.D., Ph.D.
Professor of Radiology and Bioengineering
University of Pittsburgh