Calciphylaxis : Population, Risk Factors, Diagnostic Practice, Therapeutic and Outcome (CalciWest)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Calciphylaxis

Treatments: Other: Calcific Uremic Arteriolopathy

Study type: Observational

Funder types: Other

Identifiers

NCT02854046

RC16_0164

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 2 patient groups

Calciphylaxis Cases

Description:

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

Treatment:

Other: Calcific Uremic Arteriolopathy

Witness cases

Description:

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