Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)
Recruiting · NCT07511283 · Observational (researchers observe without assigning treatment) · Lead sponsor: Odense University Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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)
Where it is running
1 location listed.
- Odense University Hospital - Odense, Denmark