CalciphylaxisNCT07511283
Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)
An observational study of Calciphylaxis and Calcific Uremic Arteriolopathy, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Calciphylaxis, Calcific Uremic Arteriolopathy, End Stage Renal Disease (ESRD)
- How many people
- 860 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2026to Jun 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic kidney disease diagnosed or suspected for calciphylaxis matched control patients, healthy reference group. National study in Denmark
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, 5000
Subagini Nagarajah, PhD, +45 40498337, subagini.nagarajah3@rsyd.dk
Alexandra Scholze, Dr.med, PhD, +45 65412402, Alexandra.Scholze@rsyd.dk
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 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.
Read the 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.
- Conditions
- Calciphylaxis, Calcific Uremic Arteriolopathy, End Stage Renal Disease (ESRD), Chronic Kidney Diseases, Nephrogenic Calciphylaxis
- Keywords
- Calciphylaxis, Calcific Uremic Arteriolopathy, Nephrogenic Calciphylaxis, End Stage Renal Disease, Chronic Kidney Diseases
- Medical subject headings
- Calciphylaxis, Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic kidney disease diagnosed or suspected for calciphylaxis | Not described | |
| Matched control patients with chronic kidney disease without calciphylaxis | Not described | |
| Age matched healthy reference group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Associations between disease status (case or control), clinical and laboratory variables, molecular parameters, and all-cause mortality will be evaluated.
Measured: 3 year follow up period
Secondary outcomes (4)
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
Measured: 3 year follow up period
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.
Measured: 3 year follow up period
Hospitalizations
Associations between disease status (case or control), clinical and laboratory variables, molecular parameters, and hospitalizations (inpatient-days of any cause) will be evaluated
Measured: 3 year follow up period
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
Measured: 3 year follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2040 (estimated)
- Study completionJun 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CalciphylaxisStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Subagini Nagarajah, PhD, Principal investigator, Odense University HospitalAlexandra Scholze, Dr.med, PhD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511283
- Sponsor's protocol ID
- S-20250043
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized individual participant data and biomaterials may be shared with researchers whose proposed use of the data and materials has been approved by the relevant ethical and data protection authorities in all involved countries, with such use governed by contractual agreements.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)
- ClinicalTrials.gov ID
- NCT07511283
- Acronym / sponsor ID
- S-20250043
- Conditions
- Calciphylaxis, Calcific Uremic Arteriolopathy, End Stage Renal Disease (ESRD), Chronic Kidney Diseases, Nephrogenic Calciphylaxis
- Keywords
- Calciphylaxis, Calcific Uremic Arteriolopathy, Nephrogenic Calciphylaxis, End Stage Renal Disease, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2040 (estimated)
- Study completion
- Jun 2040 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic kidney disease diagnosed or suspected for calciphylaxis | – | – |
| Matched control patients with chronic kidney disease without calciphylaxis | – | – |
| Age matched healthy reference group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease diagnosed or suspected for calciphylaxis matched control patients, healthy reference group. National study in Denmark
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Pain severity
Time frame: 3 year follow up period
Quality of life (QoL)
Time frame: 3 year follow up period
Hospitalizations
Time frame: 3 year follow up period
Calciphylaxis Wound Status
Time frame: 3 year follow up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Yes. Pseudonymized individual participant data and biomaterials may be shared with researchers whose proposed use of the data and materials has been approved by the relevant ethical and data protection authorities in all involved countries, with such use governed by contractual agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Subagini Nagarajah, PhD principal investigator
Odense University Hospital
Alexandra Scholze, Dr.med, PhD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Calciphylaxis and Calcific Uremic Arteriolopathy, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Subagini Nagarajah, PhD (+45 40498337, subagini.nagarajah3@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 3 year follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.