Clinical trial NCT02854046: Calciphylaxis : Population, Risk Factors, Diagnostic Practice, Therapeutic and Outcome
Official title: Calciphylaxis : Population, Risk Factors, Diagnostic Practice, Therapeutic and Outcome : a Multicentric, Retrospective Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Calciphylaxis
Keywords: calcific uremic arteriolopathy
case-control study
cohort study
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

Brief 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.


Eligibility criteria: Inclusion Criteria:

* patients ≥ 18 years with chronic renal failure with Glomerular Filtration Rate \< 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:

* realized biopsy 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.

Primary outcomes:
measure: Description of calcific uremic arteriolopathy in a French population by describing the characteristics of the population, diagnostic and treatment practices and patient outcome.
timeFrame: Up to 16 months
Secondary outcomes:
measure: Study factors determining the patient outcome with calciphylaxis
timeFrame: Up to 16 months
measure: Study case control of risk factors in the subgroup of patients in extra renal replacement therapy
timeFrame: Up to 16 months
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: Maryvonne HOURMANT, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.