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NCT Number: NCT07511283

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 3 year follow up period

    Associations between disease status (case or control), clinical and laboratory variables, molecular parameters, and all-cause mortality will be evaluated.

Secondary outcomes

  1. Pain severity

    Time frame: 3 year follow up period

    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

  2. Quality of life (QoL)

    Time frame: 3 year follow up period

    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. Hospitalizations

    Time frame: 3 year follow up period

    Associations between disease status (case or control), clinical and laboratory variables, molecular parameters, and hospitalizations (inpatient-days of any cause) will be evaluated

  4. Calciphylaxis Wound Status

    Time frame: 3 year follow up period

    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

Other outcomes

  1. Retrospective and cross-sectional: Development of calciphylaxis skin lesions

    Time frame: 2 years retrospective and at inclusion

    To determine clinical, laboratory, and molecular predictors of skin lesion development through comparison with a matched control population

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Scholze, Dr. med., PhD

CONTACT

[email protected]

+45 65412402

Subagini Nagarajah, PhD

CONTACT

[email protected]

+45 40498337

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2040
Study completion
2040
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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