Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; End Stage Renal Disease (ESRD); Calciphylaxis; Calcific Uremic Arteriolopathy; Nephrogenic Calciphylaxis

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.

• Study Type: Observational
• Enrollment (Estimated): 860

Contacts and Locations

• Study Contact: Name: Subagini Nagarajah, PhD; Phone Number: +45 40498337; Email: subagini.nagarajah3@rsyd.dk
• Study Contact Backup: Name: Alexandra Scholze, Dr. med., PhD; Phone Number: +45 65412402; Email: Alexandra.Scholze@rsyd.dk

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Subagini Nagarajah, PhD; Phone Number: +45 40498337; Email: subagini.nagarajah3@rsyd.dk
    • Contact: Alexandra Scholze, Dr.med, PhD; Phone Number: +45 65412402; Email: Alexandra.Scholze@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic kidney disease diagnosed or suspected for calciphylaxis matched control patients, healthy reference group.

National study in Denmark

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Patients with chronic kidney disease diagnosed or suspected for calciphylaxis
Matched control patients with chronic kidney disease without calciphylaxis
Age matched healthy reference group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Associations between disease status (case or control), clinical and laboratory variables, molecular parameters, and all-cause mortality will be evaluated.	3 year follow up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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	3 year follow up period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years retrospective and at inclusion

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Subagini Nagarajah, PhD, Odense University Hospital; Principal Investigator: Alexandra Scholze, Dr.med, PhD, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2040
• Study Completion (Estimated): June 1, 2040

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Calciphylaxis; Calcific Uremic Arteriolopathy; Chronic Kidney Diseases; Nephrogenic Calciphylaxis
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Renal Insufficiency; Calcium Metabolism Disorders; Calcinosis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Calciphylaxis
• Other Study ID Numbers: S-20250043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No