Calciphylaxis in people with chronic kidney disease: causes, risks, and early signs
Official title: Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)
Run by Odense University Hospital · NCT07511283 · Data updated 2026-11-12
This project will compare adults with chronic kidney disease who develop calciphylaxis to matched CKD patients who do not, collecting clinical data and biological samples to try to find risk factors and early signs.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 860 (estimated) |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense) |
| Status | Recruiting |
| Started | April 2026 |
| Main results expected | June 2040 |
| Study ends | June 2040 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT07511283 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults (≥18) with chronic kidney disease — including those with suspected or newly diagnosed calciphylaxis for the case group, CKD patients without calciphylaxis for controls, and healthy adults for the reference group.
✕Probably not a fit
People without chronic kidney disease, children under 18, or those whose calciphylaxis diagnosis is later excluded are unlikely to receive direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The Danish Calciphylaxis Research Initiative (DanCaRI) enrolls adults with CKD who have suspected or newly diagnosed calciphylaxis (cases), matched CKD controls who never developed calciphylaxis, and a healthy reference group. The design combines a two-year retrospective review with prospective follow-up for three years and systematic collection of clinical data and biological samples. Cases and controls are matched to identify differences in exposures, laboratory markers, and clinical course that might indicate causes or early indicators of calciphylaxis. Results are intended to support prevention strategies, earlier diagnosis, and the design of future treatment trials.
Why it matters
Potential benefit: If successful, this work could identify risk factors and early markers that help prevent calciphylaxis, detect it sooner, and guide development of treatments.
How similar studies have gone: Existing evidence is limited to small case series and registry reports, so a matched case-control approach with prospective follow-up is relatively novel and aims to fill a major knowledge gap.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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Odense University Hospital
Odense, Denmark Recruiting
Study contacts
- Principal investigator: Subagini Nagarajah, PhD — Odense University Hospital
- Study coordinator: Subagini Nagarajah, PhD
- Email: subagini.nagarajah3@rsyd.dk
- Phone: +45 40498337
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Human amniotic-derived mesenchymal stem cell treatment for calciphylaxis
This will try human amniotic-derived mesenchymal stem cells as a treatment for adults 18–75 who have calciphylaxis, including people with chronic kidney disease whether they are on dialysis or not.
-
Biobank for calciphylaxis research
This study is collecting patient samples to learn more about calciphylaxis, a rare condition that causes painful skin sores, in hopes of finding better treatments.
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This study tests how well three dialysis approaches work for adults with ESRD starting dialysis in China, using real-world data from routine care.
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Extra Ultrafiltration to Remove Fluid in Hemodialysis Patients
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.