Calcific Uremic Arteriolopathy, Calciphylaxis, Chronic Kidney Diseases, End Stage Renal Disease (ESRD), Nephrogenic Calciphylaxis
Conditions
Keywords
Calciphylaxis, Calcific Uremic Arteriolopathy, Nephrogenic Calciphylaxis, End Stage Renal Disease, Chronic Kidney Diseases
Brief summary
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.
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.
Interventions
None listed
Sponsors
Odense University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain severity | 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 |
| Quality of life (QoL) | 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. |
| Hospitalizations | 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 |
| Calciphylaxis Wound Status | 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 |
Countries
Denmark
Contacts
CONTACTSubagini Nagarajah, PhD
CONTACTAlexandra Scholze, Dr. med., PhD
PRINCIPAL_INVESTIGATORSubagini Nagarajah, PhD
Odense University Hospital
PRINCIPAL_INVESTIGATORAlexandra Scholze, Dr.med, PhD
Odense University Hospital
Outcome results
None listed