Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07511283

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

Led by Odense University Hospital · Updated on 2026-04-06

860

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Calciphylaxis is a rare and serious condition characterized by calcification in small blood vessels of the skin, mainly affecting people with chronic kidney disease (CKD). Knowledge about its causes and risk factors is limited, and there is currently no proven effective treatment. This research aims to compare patients with CKD who develop calciphylaxis to those with CKD who do not, to learn more that may help prevent and detect the condition earlier and guide new treatments. The study includes a retrospective part covering two years and a prospective follow-up period of three years. It involves three groups: patients with CKD and calciphylaxis, matched patients with CKD without calciphylaxis, and a healthy reference group for comparison. Clinical data and biological samples are collected from participants to support this research. Participants will be monitored for three years, during which researchers will assess outcomes including all-cause mortality, pain severity, quality of life, hospitalizations, and wound status related to calciphylaxis. The study collects detailed information and samples to help understand the disease better and improve future care. Participation involves providing consent and being able to join clinical assessments as determined by investigators.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of chronic kidney disease (CKD)
  • Suspicion or new diagnosis of calciphylaxis (for cases)
  • Ability to provide informed consent
  • Ability to participate in a clinical study as assessed by the investigator
  • Written informed consent provided
  • For controls: CKD without calciphylaxis
  • For healthy reference group: Age 18 years or older and self-assessed as healthy confirmed by investigators
Not Eligible

You will not qualify if you...

  • Calciphylaxis diagnosis excluded (for cases)
  • Diagnosis of calciphylaxis (for controls)
  • For healthy controls up to 60 years old: estimated glomerular filtration rate (eGFR) below 60 ml/min/1.72m2
  • For healthy controls over 60 years old: eGFR below age-adjusted reference range according to Danish Society of Nephrology

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - 3 years

Participants with chronic kidney disease and healthy controls are observed over time to collect clinical data and biological samples.

Periodic visits for clinical assessments and sample collection

Trial Site Locations

Total: 1 location

1

Odense University Hospital

Odense, Denmark, 5000

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Research Team

S

Subagini Nagarajah, PhD

A

Alexandra Scholze, Dr. med., PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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