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CompletedNCT02854046CalciWestUpdated Jun 24, 2026

Calciphylaxis : Population, Risk Factors, Diagnostic Practice, Therapeutic and Outcome

An observational study in Calciphylaxis, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study summary

Calciphylaxis, also called Calcific Uremic Arteriolopathy (CUA) is a lethal affection mostly affecting patient in end stage renal disease. The survival rate is described around 20 to 46% at one year.

Clinical presentation is very painful skin lesions with ulceration mostly located on the trunk or thigh.

Current knowledge about physiopathology, diagnostic practice and therapeutic is very limited.

Actually there is no European study about calciphylaxis and risk factors, diagnostic practice and outcome factors.

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Conditions studied

  • Calciphylaxis

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Keywords

  • calcific uremic arteriolopathy
  • case-control study
  • cohort study
03

In context

Calciphylaxis

23 studies on the registry are indexed under Calciphylaxis; 10 are open to participants now.

This study's enrollment of 80 is below the median of 450 across 10 observational studies indexed under Calciphylaxis.

Browse Calciphylaxis studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with advanced chronic kidney disease (DFG estimation \< 30 ml/min/1.73m² - beyond 3B stage) with/without subtitute therapy who has presented a case of calciphylaxis between 2006 and 2016 in the Régions of Pays de la Loire, Centre Val de Loire, Bretagne and Poitou-Charentes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients ≥ 18 years with chronic renal failure with \< 30ml/min/1,73m²
  • diagnosis of calciphylaxis between 2006 and 2016
  • living in the Regions of Bretagne, Pays de la Loire, Poitou-Charentes or Centre Val de Loire.

Exclusion criteria

Exclusion Criteria:

  • realized in favor of differential diagnosis
  • significant arterial lesion of lesion area or differential diagnosis more valid
  • if the diagnosis is not based on the following criteria: 3 clinical criteria or 2 clinical criteria and biopsy in favor, criteria which are :

    • Patient in chronic hemodialysis or stade 4 chronic kidney disease
    • At least 2 painful sores and hardly curable with concomitant painful purpura
    • Sore and purpura localisation in trunk, extremities and penis.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Calciphylaxis Cases

    Adult patients with advanced chronic kidney disease (DFG estimation \< 30 ml/min/1.73m² - beyond 3B stage) with/without substitute therapy who has presented a case of calciphylaxis (Calcific Uremic Arteriolopathy) between 2006 and 2016 in the Regions of Pays de la Loire, Centre Val de Loire, Bretagne and Poitou-Charentes

    Other: Calcific Uremic Arteriolopathy

  • Witness cases

    Selected anonymously in French national register REIN. Matched to Calciphylaxis Cases according to gender, age, treatment by extrarenal purification at the timepoint "onset of the lesions" and REIN regions belonging

Interventions

  • OtherCalcific Uremic Arteriolopathy
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What researchers measure

Primary outcomes

  1. Description of calcific uremic arteriolopathy in a French population by describing the characteristics of the population, diagnostic and treatment practices and patient outcome.

    Time frame: Up to 16 months

Secondary outcomes

  1. Study factors determining the patient outcome with calciphylaxis

    Time frame: Up to 16 months

  2. Study case control of risk factors in the subgroup of patients in extra renal replacement therapy

    Time frame: Up to 16 months

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Study locations

1 site
  • CHU de Nantes
    Nantes, 44093, France
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References and documents

Publications

  • Brandenburg VM, Kramann R, Rothe H, Kaesler N, Korbiel J, Specht P, Schmitz S, Kruger T, Floege J, Ketteler M. Calcific uraemic arteriolopathy (calciphylaxis): data from a large nationwide registry. Nephrol Dial Transplant. 2017 Jan 1;32(1):126-132. doi: 10.1093/ndt/gfv438. PubMed 26908770 ↗
  • Floege J, Kubo Y, Floege A, Chertow GM, Parfrey PS. The Effect of Cinacalcet on Calcific Uremic Arteriolopathy Events in Patients Receiving Hemodialysis: The EVOLVE Trial. Clin J Am Soc Nephrol. 2015 May 7;10(5):800-7. doi: 10.2215/CJN.10221014. Epub 2015 Apr 17. PubMed 25887067 ↗
  • Fine A, Zacharias J. Calciphylaxis is usually non-ulcerating: risk factors, outcome and therapy. Kidney Int. 2002 Jun;61(6):2210-7. doi: 10.1046/j.1523-1755.2002.00375.x. PubMed 12028462 ↗
  • Weenig RH, Sewell LD, Davis MD, McCarthy JT, Pittelkow MR. Calciphylaxis: natural history, risk factor analysis, and outcome. J Am Acad Dermatol. 2007 Apr;56(4):569-79. doi: 10.1016/j.jaad.2006.08.065. Epub 2006 Dec 1. PubMed 17141359 ↗
  • Gaisne R, Pere M, Menoyo V, Hourmant M, Larmet-Burgeot D. Calciphylaxis epidemiology, risk factors, treatment and survival among French chronic kidney disease patients: a case-control study. BMC Nephrol. 2020 Feb 26;21(1):63. doi: 10.1186/s12882-020-01722-y. PubMed 32101140 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02854046
Responsible party
Sponsor
First posted
Aug 3, 2016
Start date
Jul 1, 2016
Primary completion
Oct 31, 2016
Completion
Oct 31, 2016
Last update
Jun 24, 2026

Study contacts

Maryvonne HOURMANT, PHD
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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