Rheopheresis as Adjuvant Treatment of Calciphylaxis

Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial

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.

Calciphylaxis, also known as uremic calcifying arteriolopathy (UCA), is a rare disease that causes painful ischemic skin lesions due to microvascular calcification and thrombosis of the dermis and subcutaneous adipose tissue. Patients with end-stage renal disease (ESRD) are the main target for calciphylaxis. Rheopheresis is a therapeutic apheresis to treat microcirculatory disorders. This double filtration plasmapheresis eliminates a defined spectrum of high molecular weight proteins from human plasma including relevant factors for vascular inflammation and thrombose. The investigators propose a prospective randomized controlled trial to compared the efficacy of rheopheresis as adjuvant treatment to the standard of care compared to standard care with Sham-apheresis.

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.