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

Overview

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.

Full Title of Study: “Calciphylaxis : Population, Risk Factors, Diagnostic Practice, Therapeutic and Outcome : a Multicentric, Retrospective Cohort”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: October 31, 2016

Interventions

  • Other: Calcific Uremic Arteriolopathy

Arms, 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Study factors determining the patient outcome with calciphylaxis
    • Time Frame: Up to 16 months
  • Study case control of risk factors in the subgroup of patients in extra renal replacement therapy
    • Time Frame: Up to 16 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nantes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maryvonne HOURMANT, PHD, Principal Investigator, Nantes University Hospital

References

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.

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