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

Calciphylaxis Clinical Trial

— CalciWest  

Official title:

Calciphylaxis : Population, Risk Factors, Diagnostic Practice, Therapeutic and Outcome : a Multicentric, Retrospective Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854046
• Other study ID #: RC16_0164
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: October 31, 2016

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calciphylaxis

Intervention

Other:
• Calcific Uremic Arteriolopathy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

References & Publications (4)

Brandenburg VM, Kramann R, Rothe H, Kaesler N, Korbiel J, Specht P, Schmitz S, Krüger 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. — View Citation

Fine A, Zacharias J. Calciphylaxis is usually non-ulcerating: risk factors, outcome and therapy. Kidney Int. 2002 Jun;61(6):2210-7. — View 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. — View 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. Epub 2006 Dec 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Study factors determining the patient outcome with calciphylaxis		Up to 16 months
Secondary	Study case control of risk factors in the subgroup of patients in extra renal replacement therapy		Up to 16 months