Calciphylaxis : Population, Risk Factors, Diagnostic Practice, Therapeutic and Outcome
NCT ID: NCT02854046
Last Updated: 2021-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2016-07-01
2016-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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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
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
No interventions assigned to this group
Interventions
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Calcific Uremic Arteriolopathy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Maryvonne HOURMANT, PHD
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
References
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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.
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.
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.
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.
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.
Other Identifiers
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RC16_0164
Identifier Type: -
Identifier Source: org_study_id
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