Rheopheresis as Adjuvant Treatment of Calciphylaxis
Recruiting · NCT04654000 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Lille
View the official record on ClinicalTrials.gov →Interventions studied
Rheopheresis procedureSham-apheresis
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
29 locations listed.
- 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 Boulogne sur Mer - Boulogne-sur-Mer, France
- CHU de Bordeaux - Bourdeaux, France
- CHRU de Brest - Brest, France
- CH de Béthune - Béthune, France
- CHU de Caen - Caen, France
- Hôpital Nord Michallon, CHU de Grenoble - Grenoble, France
- Centre ECHO Laval - Laval, France
- Centre ECHO Le Mans - Le Mans, France
- Hôpital Privé La Louvière - Lille, France
- Hop Claude Huriez Chu Lille - Lille, France
- CHR de Limoges - Limoges, France
- Hôpital Lyon Sud - Lyon, France
- Hôpital Saint Joseph Saint Luc - Lyon, France
- Institut Phocéen de Néphrologie - Clinique Bouchard - Marseille, France
- Hôpital de la Conception, AP-HM - Marseille, France
- CHU de Montpellier - Montpellier, France
- CHU de Nantes - Nantes, France
- CH de Niort - Niort, France
- CHU de Reims - Reims, France
- CHU de Toulouse - Toulouse, France
- Clinique Saint Exupéry - Toulouse, France
- CH de Valenciennes - Valenciennes, France
- CHRU de Nancy Brabois - Vandœuvre-lès-Nancy, France
- Centre Hospitalier Bretagne Atlantique - Vannes, France
- CH de Vichy - Vichy, France