Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)

Odense University Hospital860 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

860

Conditions

Calciphylaxis

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Cases * Age ≥18 years. * CKD. * 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. Controls * Age ≥18 years. * CKD * 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 Exclusion Criteria: Cases \- the calciphylaxis diagnosis becomes excluded Controls - Being diagnosed with calciphylaxis Healthy controls Up to 60 years of age: eGFR below 60 ml/min/1.72m2. \- Over 60 years of age: eGFR below the 95% confidence interval for eGFR adjusted for age (Danish Society of Nephrology references ranges)

Outcomes

Primary Outcomes

All-cause mortality

Associations between disease status (case or control), clinical and laboratory variables, molecular parameters, and all-cause mortality will be evaluated.