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

September 20, 2021 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 16 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Maryvonne HOURMANT, PHD, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

October 31, 2016

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC16_0164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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