Rheopheresis as an add-on treatment for calciphylaxis in people on hemodialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, controlled trial comparing rheopheresis added to standard care versus standard care with sham-apheresis in patients with ulcerated or necrotic calciphylaxis on hemodialysis. Rheopheresis is a double-filtration plasmapheresis that removes selected high–molecular-weight plasma proteins linked to vascular inflammation and thrombosis. Participants meeting inclusion criteria will be randomized to receive active rheopheresis procedures or sham procedures in addition to usual multidisciplinary management. The trial will monitor safety and clinical outcomes such as lesion healing, pain, and progression over a defined follow-up period.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU d'Arras
  Arras, France Recruiting
• CHU de Besançon, Hôpital Jean Minjoz
  Besançon, France Recruiting
• CH de Béthune
  Béthune, France Recruiting
• CH de Boulogne sur Mer
  Boulogne-sur-Mer, France Recruiting
• Hôpital Nord Michallon, CHU de Grenoble
  Grenoble, France Recruiting
• Centre ECHO Laval
  Laval, France Recruiting

Study contacts

• Principal investigator: Arnaud Lionet, MD — University Hospital, Lille
• Study coordinator: Arnaud Lionet, MD
• Email: arnaud.lionet@chru-lille.fr
• Phone: 0320445000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.