Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Calciphylaxis, Calcific Uremic Arteriolopathy, End Stage Renal Disease (ESRD), Chronic Kidney Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed description
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.
Primary outcome measures
- All-cause mortality [Time frame: 3 year follow up period]
Secondary outcome measures (4)
- Pain severity [Time frame: 3 year follow up period]
- Quality of life (QoL) [Time frame: 3 year follow up period]
- Hospitalizations [Time frame: 3 year follow up period]
- Calciphylaxis Wound Status [Time frame: 3 year follow up period]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Denmark · 1 center
- Odense University Hospital — Odense
Identifiers
NCT: NCT07511283 · S-20250043