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

NCT02854046 | Completed

• 1 other identifier: RC16_0164
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Calciphylaxis

Keywords

calcific uremic arteriolopathy; case-control study; cohort study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

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

Other: 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

Interventions

Calcific Uremic Arteriolopathy OTHER

Calciphylaxis Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with advanced chronic kidney disease (DFG estimation \< 30 ml/min/1.73m² - beyond 3B stage) with/without subtitute therapy who has presented a case of calciphylaxis between 2006 and 2016 in the Régions of Pays de la Loire, Centre Val de Loire, Bretagne and Poitou-Charentes

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Related Publications (5)

• 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.

  PMID: 26908770 BACKGROUND

• 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.

  PMID: 25887067 BACKGROUND

• 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.

  PMID: 12028462 BACKGROUND

• 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.

  PMID: 17141359 BACKGROUND

• 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.

  PMID: 32101140 DERIVED

MeSH Terms

Conditions

Calciphylaxis

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Maryvonne HOURMANT, PHD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 3, 2016
• Study Start: July 1, 2016
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share