RecruitingNot ApplicableNCT04654000

Rheopheresis as Adjuvant Treatment of Calciphylaxis

Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial

Sponsor

University Hospital, Lille

Enrollment

138 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

Rare Diseases End Stage Renal Disease Metabolic Disorder

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether rheopheresis — a blood-filtering procedure that removes certain proteins from the blood — can help treat calciphylaxis, a rare and painful condition where calcium deposits form in blood vessels and the skin, causing wounds and tissue death. It is most common in people on dialysis. **You may be eligible if...** - You have been diagnosed with calciphylaxis with at least one open wound or area of tissue death - You are on hemodialysis (kidney dialysis) due to end-stage kidney disease - You weigh more than 30 kg - You are enrolled in a French social security system **You may NOT be eligible if...** - Your overall physical condition is very poor (Karnofsky score below 30%) - Your life expectancy (apart from the calciphylaxis) is less than 6 months - You have an uncontrolled infection - You have a known allergy to albumin - You are pregnant or breastfeeding - You have severe cognitive or psychiatric conditions that prevent giving consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERheopheresis procedure

rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins

PROCEDURESham-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.

Locations(29)

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

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NCT04654000

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