Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 860
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Calciphylaxis is a rare yet life-threatening condition involving pronounced calcification in small blood vessels of the skin.
Knowledge about its underlying mechanisms and contributing risk factors remains limited. Chronic kidney disease is one of the strongest disease predictors. No evidence based effective therapy is currently available. Research on the topic is mainly hindered by the condition's rarity.
The study Calciphylaxis in patients with chronic kidney disease - A study of the Danish Calciphylaxis Research Initiative (DanCaRI) is set up to facilitate the systematic retrospective and prospective comparison of patients with chronic kidney disease and calciphylaxis to matched patients with chronic kidney disease who did not develop calciphylaxis thereby providing new knowledge that can support prevention, early detection, and new treatment approaches.
详细描述
Calciphylaxis is a rare yet life-threatening condition involving pronounced calcification in small blood vessels of the skin.
Knowledge about its underlying mechanisms and contributing risk factors remains limited. Chronic kidney disease is one of the strongest disease predictors. No evidence based effective therapy is currently available. Research on the topic is mainly hindered by the condition's rarity.
The study Calciphylaxis in patients with chronic kidney disease - A study of the Danish Calciphylaxis Research Initiative (DanCaRI) is set up to facilitate the systematic retrospective (two years) and prospective (three years follow-up period) comparison of patients with chronic kidney disease and calciphylaxis (cases) to matched patients with chronic kidney disease who did not develop calciphylaxis (controls) thereby providing new knowledge that can support prevention, early detection, and new treatment approaches.
The study collects clinical data and biological samples. A healthy group is part of the study to enable comparison to reference parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years.
- •Suspicion of calciphylaxis or newly diagnosed calciphylaxis episode. The suspicion or diagnosis of calciphylaxis is a mutual decision of the involved medical specialties (nephrologist, dermatologist, pathologist, other).
- •Ability to give informed consent.
- •Ability to participate in a clinical study as assessed by the local investigator.
- •Provides written informed consent.
- •Age ≥18 years.
- •Ability to give informed consent.
- •Ability to participate in a clinical study as assessed by the local investigator.
- •Provides written informed consent.
- •Healthy reference group
- •Age ≥18 years.
- •Self-assessed as healthy, confirmed by local investigators at inclusion
排除标准
- •- the calciphylaxis diagnosis becomes excluded
- •Controls - Being diagnosed with calciphylaxis
- •Healthy controls Up to 60 years of age: eGFR below 60 ml/min/1.72m
- •- Over 60 years of age: eGFR below the 95% confidence interval for eGFR adjusted for age (Danish Society of Nephrology references ranges)
研究组 & 干预措施
Patients with chronic kidney disease diagnosed or suspected for calciphylaxis
Matched control patients with chronic kidney disease without calciphylaxis
Age matched healthy reference group
结局指标
主要结局
All-cause mortality
时间窗: 3 year follow up period
Associations between disease status (case or control), clinical and laboratory variables, molecular parameters, and all-cause mortality will be evaluated.
次要结局
- Pain severity(3 year follow up period)
- Quality of life (QoL)(3 year follow up period)
- Hospitalizations(3 year follow up period)
- Calciphylaxis Wound Status(3 year follow up period)