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Rheopheresis as Adjuvant Treatment of Calciphylaxis

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Lille
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In plain words

What the trial is, and whether it could suit you

The investigators propose to set up a prospective randomized controlled trial to control the security and assess the efficacy of adjuvant treatment by rheopheresis in necrotizing-ulcered calciphylaxis in the hemodialysis population.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Calciphylaxis with at least one ulcerated or necrotizing lesion * End stage renal disease requiring hemodialysis * Weight superior to 30kg * Subject affiliated to or beneficiary of a social security system * Subject having signed written informed consent A patient with progressing calciphylaxis to ulcerate or necrosis despite conventional treatment may also be included. Exclusion Criteria: * KARNOFSKY Performance Status Scale inferior to 30% * Life expectancy (independently of calciphylaxis) estimated \< 6 months according to a referring physician expert in hemodialysis * Uncontrolled infection (persistence of fever despite appropriate antibiotic therapy) * Common variable immunodeficiency * Albumin allergy * Contra-indication to stop anti-vitamin K treatment * Severe cognitive or psychiatric disorders, patients unable to give an informed consent or unwilling to participate in the study * Pregnancy or breastfeeding and all the other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without contentment, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations.
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What it tests

  • Rheopheresis procedure
  • Sham-apheresis
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Where

29 sites
CHU d'Angers
Angers, France
CHU d'Arras
Arras, France
CHU d'Auxerre
Auxerre, France
CHU de Besançon, Hôpital Jean Minjoz
Besançon, France
CH de Béthune
Béthune, France
CH de Boulogne sur Mer
Boulogne-sur-Mer, France
CHU de Bordeaux
Bourdeaux, France
CHRU de Brest
Brest, France

…and 21 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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