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

Completed

• Conditions: Calciphylaxis
• Interventions: Other: Calcific Uremic Arteriolopathy

• Registration Number: NCT02854046
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-03
• Primary Completion: 2016-10-31
• Study Completion: 2016-10-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Calciphylaxis Cases	Calcific Uremic Arteriolopathy	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

Primary Outcome Measures

Name	Time	Method
Description of calcific uremic arteriolopathy in a French population by describing the characteristics of the population, diagnostic and treatment practices and patient outcome.	Up to 16 months

Secondary Outcome Measures

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