Actively Recruiting
Rheopheresis as Adjuvant Treatment of Calciphylaxis
Led by University Hospital, Lille · Updated on 2026-02-12
138
Participants Needed
29
Research Sites
216 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
D
Direction Générale de l'Offre de Soins
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Rheopheresis as Adjuvant Treatment of Calciphylaxis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- KARNOFSKY Performance Status Scale inferior to 30%
- Life expectancy independently of calciphylaxis estimated less than 6 months according to a referring physician expert in hemodialysis
- Uncontrolled infection with 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 other special protection categories according to the French Code de la Santé Publique (CSP): patients under legal supervision, hospitalized without contentment, admitted in social or sanitary care structures not for research, and patients in emergency situations.
AI-Screening
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Trial Site Locations
Total: 29 locations
1
CHU d'Angers
Angers, France, 49933
Not Yet Recruiting
2
CHU d'Arras
Arras, France, 62022
Actively Recruiting
3
CHU d'Auxerre
Auxerre, France, 89011
Not Yet Recruiting
4
CHU de Besançon, Hôpital Jean Minjoz
Besançon, France, 25000
Actively Recruiting
5
CH de Béthune
Béthune, France, 62408
Actively Recruiting
6
CH de Boulogne sur Mer
Boulogne-sur-Mer, France, 62321
Actively Recruiting
7
CHU de Bordeaux
Bourdeaux, France, 33076
Not Yet Recruiting
8
CHRU de Brest
Brest, France, 29609
Not Yet Recruiting
9
CHU de Caen
Caen, France, 14033
Not Yet Recruiting
10
Hôpital Nord Michallon, CHU de Grenoble
Grenoble, France, 38043
Actively Recruiting
11
Centre ECHO Laval
Laval, France, 53015
Actively Recruiting
12
Centre ECHO Le Mans
Le Mans, France, 72000
Actively Recruiting
13
Hôpital Privé La Louvière
Lille, France, 59000
Actively Recruiting
14
Hop Claude Huriez Chu Lille
Lille, France
Actively Recruiting
15
CHR de Limoges
Limoges, France, 87042
Actively Recruiting
16
Hôpital Lyon Sud
Lyon, France, 69495
Not Yet Recruiting
17
Hôpital Saint Joseph Saint Luc
Lyon, France, 69635
Not Yet Recruiting
18
Institut Phocéen de Néphrologie - Clinique Bouchard
Marseille, France, 13006
Not Yet Recruiting
19
Hôpital de la Conception, AP-HM
Marseille, France, 13385
Actively Recruiting
20
CHU de Montpellier
Montpellier, France, 34295
Actively Recruiting
21
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
22
CH de Niort
Niort, France, 79000
Not Yet Recruiting
23
CHU de Reims
Reims, France, 51092
Actively Recruiting
24
CHU de Toulouse
Toulouse, France, 31059
Actively Recruiting
25
Clinique Saint Exupéry
Toulouse, France, 31400
Not Yet Recruiting
26
CH de Valenciennes
Valenciennes, France, 59300
Actively Recruiting
27
CHRU de Nancy Brabois
Vandœuvre-lès-Nancy, France, 54500
Not Yet Recruiting
28
Centre Hospitalier Bretagne Atlantique
Vannes, France, 56017
Not Yet Recruiting
29
CH de Vichy
Vichy, France, 03200
Not Yet Recruiting
Research Team
A
Arnaud Lionet, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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