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

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ClinicalTrials.gov Identifier: NCT02854046
Recruitment Status : Unknown
Verified July 2016 by Nantes University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Calciphylaxis Other: Calcific Uremic Arteriolopathy

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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Calciphylaxis : Population, Risk Factors, Diagnostic Practice, Therapeutic and Outcome : a Multicentric, Retrospective Cohort
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Study factors determining the patient outcome with calciphylaxis [ Time Frame: Up to 16 months ]
  2. Study case control of risk factors in the subgroup of patients in extra renal replacement therapy [ Time Frame: Up to 16 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854046


Contacts
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Contact: David LARMET BURGEOT, MSc +33 (0)632421652 larmet.david@orange.fr
Contact: Maryvonne HOURMANT, PHD +33(0)240087453 maryvonne.hourmant@chu-nantes.fr

Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Maryvonne HOURMANT, PHD Nantes University Hospital