An observational study in Calciphylaxis, Calcific Uremic Arteriolopathy and End Stage Renal Disease (ESRD), sponsored by Odense University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Odense University Hospital · Observational
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.
23 studies on the registry are indexed under Calciphylaxis; 10 are open to participants now.
This study's planned enrollment of 860 is above the median of 450 across 10 observational studies indexed under Calciphylaxis.
Browse Calciphylaxis studies →Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with chronic kidney disease diagnosed or suspected for calciphylaxis matched control patients, healthy reference group.
National study in Denmark
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cases
Controls
Healthy reference group
Exclusion Criteria:
Cases
- the calciphylaxis diagnosis becomes excluded
Controls - Being diagnosed with calciphylaxis
Healthy controls Up to 60 years of age: 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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All-cause mortality
Associations between disease status (case or control), clinical and laboratory variables, molecular parameters, and all-cause mortality will be evaluated.
Time frame: 3 year follow up period
Pain severity
Associations between disease status (case or control), clinical and laboratory variables, molecular parameters, and pain severity (determined using Wong-Baker Faces scale) will be evaluated
Time frame: 3 year follow up period
Quality of life (QoL)
Associations between disease status (case or control), clinical and laboratory variables, molecular parameters, and QoL (determined using the Edmonton Symptom Assessment System-Revised: Renal (ESAS-r: Renal)) will be evaluated.
Time frame: 3 year follow up period
Hospitalizations
Associations between disease status (case or control), clinical and laboratory variables, molecular parameters, and hospitalizations (inpatient-days of any cause) will be evaluated
Time frame: 3 year follow up period
Calciphylaxis Wound Status
Associations between clinical and laboratory variables, as well as molecular parameters, and calciphylaxis wound status (determined using the Bates-Jensen Wound Assessment Tool (BWAT) modified for DanCaRI) will be evaluated
Time frame: 3 year follow up period
Retrospective and cross-sectional: Development of calciphylaxis skin lesions
To determine clinical, laboratory, and molecular predictors of skin lesion development through comparison with a matched control population
Time frame: 2 years retrospective and at inclusion
Plan to share: Yes — Pseudonymized individual participant data and biomaterials may be shared with researchers whose proposed use of the data and materials has been approved by the relevant ethical and data protection authorities in all involved countries, with such use governed by contractual agreements.
Supporting information: Study protocol
Access criteria: Reasonable scientific rationale for the data to be used for the requested purpose. The required resources must be available in order to comply with the request.
No publications or documents are linked to this record.
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