Rheopheresis as Adjuvant Treatment of Calciphylaxis (RHEO-CAL)
Metabolic Disorder, End Stage Renal Disease, Rare Diseases
About this trial
This is an interventional diagnostic trial for Metabolic Disorder focused on measuring Calciphylaxis, Rheopheresis, Hemodialysis, Chronic kidney disease
Eligibility Criteria
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.
Sites / Locations
- Hop Claude Huriez Chu Lille
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Rheopheresis group
Sham-apheresis group
In addition to the standards of care, the experimental group will carry out the rheopheresis in two stages: Stage 1: induction treatment: 3 apheresis sessions during the first week (w0; i.e. between D1 and D7) and then 2 apheresis sessions each week for 3 weeks (from w1 to w3; i.e. between D8 and D28) ; Step 2: maintenance treatment with 1 apheresis session per week until the 11th week (i.e. between D29 and D84).
In addition to the standards of care, the comparator group will carry out Sham-apheresis sessions according to the same scheme as the rheopheresis sessions of the experimental group.