Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
138 participants
INTERVENTIONAL
2023-03-07
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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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).
Rheopheresis procedure
rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins
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.
Sham-apheresis
Sham-apheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient.
Interventions
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Rheopheresis procedure
rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins
Sham-apheresis
Sham-apheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Direction Générale de l'Offre de Soins
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Arnaud Lionet, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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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 Béthune
Béthune, , France
CH de Boulogne sur Mer
Boulogne-sur-Mer, , France
CHU de Bordeaux
Bourdeaux, , France
CHRU de Brest
Brest, , 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
Countries
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Central Contacts
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Facility Contacts
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Laurence VRIGNEAUD, Dr
Role: primary
Stanislas Bataille, Dr
Role: primary
Other Identifiers
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2020-A02896-33
Identifier Type: OTHER
Identifier Source: secondary_id
2020_05
Identifier Type: -
Identifier Source: org_study_id
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