Calciphylaxis in people with chronic kidney disease: causes, risks, and early signs
Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)
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 |
|---|---|
| Enrollment | 860 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense) |
| Trial ID | NCT07511283 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Odense
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.