The Eurocyst Initiative: Building a Reference Center Network Across EUROpe to Establish a Large-scale Longitudinal Observational Cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,100
- 试验地点
- 14
- 主要终点
- disease progression
研究概览
简要总结
EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational cohort study has the potential to identify progression factors and biomarkers, and to assess disease stage specific mortality, morbidity and health care costs.
详细描述
The EuroCYST Initiative aims to build a network of ADPKD reference centers across Europe and to establish a large-scale observational cohort of ADPKD patients for the purpose of studying the pathogenesis, rate of disease progression, progression rate modifiers, disease stage specific morbidity, mortality, health economic issues and the predictive value of biomarkers in ADPKD. Overall 1,100 patients will be enrolled in 14 study sites across Europe and will be followed up for at least three years. The ADPKD reference center network across Europe and the observational cohort study will enable European ADPKD researchers to gain insight into the natural history, heterogeneity and associated complications of the disease as well as how it affects the lives of patients across Europe.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥ 18 years;
- •Clinical diagnosis of ADPKD based on kidney imaging and family history;
- •Estimated Glomerular Filtration Rate (eGFR) ≥ 30 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI)- formula);
- •Provided written informed consent.
排除标准
- •Receiving chronic renal replacement therapy before enrollment (dialysis, allograft) or anticipated in the following 12 months after enrollment;
- •Participation in a clinical trial aiming to modify disease outcome one year or less before enrollment in the EuroCYST study;
- •New York Heart Association (NYHA) stadium IV.
结局指标
主要结局
disease progression
时间窗: participants will be followed annually for at least 3 years
Investigate disease progression and association of disease biomarkers with the onset and severity of ADPKD-related outcomes.
次要结局
- QOL (Quality of Life)(participants will be followed annually for at least 3 years)
研究者
Andreas L. Serra
MD
University of Zurich