Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
France
CHU d'Angers
NOT_YET_RECRUITING
Angers
CHU d'Arras
RECRUITING
Arras
CHU d'Auxerre
NOT_YET_RECRUITING
Auxerre
CHU de Besançon, Hôpital Jean Minjoz
RECRUITING
Besançon
CH de Béthune
RECRUITING
Béthune
CH de Boulogne sur Mer
RECRUITING
Boulogne-sur-mer
CHU de Bordeaux
NOT_YET_RECRUITING
Bourdeaux
CHRU de Brest
NOT_YET_RECRUITING
Brest
CHU de Caen
NOT_YET_RECRUITING
Caen
Hôpital Nord Michallon, CHU de Grenoble
RECRUITING
Grenoble
Centre ECHO Laval
RECRUITING
Laval
Centre ECHO Le Mans
RECRUITING
Le Mans
Hop Claude Huriez Chu Lille
RECRUITING
Lille
Hôpital Privé La Louvière
RECRUITING
Lille
CHR de Limoges
RECRUITING
Limoges
Hôpital Lyon Sud
NOT_YET_RECRUITING
Lyon
Hôpital Saint Joseph Saint Luc
NOT_YET_RECRUITING
Lyon
Hôpital de la Conception, AP-HM
RECRUITING
Marseille
Institut Phocéen de Néphrologie - Clinique Bouchard
NOT_YET_RECRUITING
Marseille
CHU de Montpellier
RECRUITING
Montpellier
CHU de Nantes
RECRUITING
Nantes
CH de Niort
NOT_YET_RECRUITING
Niort
CHU de Reims
RECRUITING
Reims
CHU de Toulouse
RECRUITING
Toulouse
Clinique Saint Exupéry
NOT_YET_RECRUITING
Toulouse
CH de Valenciennes
RECRUITING
Valenciennes
CHRU de Nancy Brabois
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Centre Hospitalier Bretagne Atlantique
NOT_YET_RECRUITING
Vannes
CH de Vichy
NOT_YET_RECRUITING
Vichy
Contact Information
Primary
Arnaud Lionet, MD
arnaud.lionet@chru-lille.fr
0320445000
Time Frame
Start Date: 2023-03-07
Estimated Completion Date: 2027-05
Participants
Target number of participants: 138
Treatments
Experimental: Rheopheresis 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).
Sham_comparator: Sham-apheresis group
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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Lille
Collaborators: Direction Générale de l'Offre de Soins