Odense University Hospital
Odense, 5000, Denmark
Location status: Recruiting
Location contact
Alexandra Scholze, Dr.med, PhD
CONTACT
Subagini Nagarajah, PhD
CONTACT
NCT Number: NCT07511283
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Odense, 5000, Denmark
Location status: Recruiting
Alexandra Scholze, Dr.med, PhD
CONTACT
Subagini Nagarajah, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cases
Controls
Healthy reference group
Exclusion criteria
Cases
Controls - Being diagnosed with calciphylaxis
Healthy controls Up to 60 years of age: eGFR below 60 ml/min/1.72m2.
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.
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
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.
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
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
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
Contact information is provided by the study sponsor or research team.
Alexandra Scholze, Dr. med., PhD
CONTACT
Subagini Nagarajah, PhD
CONTACT
Odense University Hospital
Other
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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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