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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

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

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

860 Participants
are grouped into 3 trial groups
Group A: Patients with chronic kidney disease diagnosed or suspected for calciphylaxis
Group B: Matched control patients with chronic kidney disease without calciphylaxis
Group C: Age matched healthy reference group

Trial outcomes

Primary outcomes

1

All-cause mortality

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

Time frame
3 year follow up period

Secondary outcomes

1

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

Time frame
3 year follow up period
2

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.

Time frame
3 year follow up period
3

Hospitalizations

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

Time frame
3 year follow up period
4

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

Time frame
3 year follow up period

Other outcomes

1

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

Time frame
2 years retrospective and at inclusion

Sponsors and contacts

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