Rheopheresis as Adjuvant Treatment of Calciphylaxis
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Metabolic Disorder, End Stage Renal Disease, Rare Diseases
In brief
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.
Key facts
- Study ID
- NCT04654000
- Run by
- University Hospital, Lille
- People needed
- 138
- Starts
- 2023-03-07
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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
- CHU d'Arras — Arras, France (enrolling)
- CHU de Besançon, Hôpital Jean Minjoz — Besançon, France (enrolling)
- Hôpital de la Conception, AP-HM — Marseille, France (enrolling)
- CHU de Montpellier — Montpellier, France (enrolling)
- CHU de Nantes — Nantes, France (enrolling)
- CH de Béthune — Béthune, France (enrolling)
- CHU de Reims — Reims, France (enrolling)
- CHU de Toulouse — Toulouse, France (enrolling)
- Hôpital Nord Michallon, CHU de Grenoble — Grenoble, France (enrolling)
- CH de Valenciennes — Valenciennes, France (enrolling)
- Centre ECHO Laval — Laval, France (enrolling)
- Centre ECHO Le Mans — Le Mans, France (enrolling)
- Hôpital Privé La Louvière — Lille, France (enrolling)
- Hop Claude Huriez Chu Lille — Lille, France (enrolling)
- CHR de Limoges — Limoges, France (enrolling)
- CH de Boulogne sur Mer — Boulogne-sur-Mer, France (enrolling)
- CH de Vichy — Vichy, France
- CHU d'Auxerre — Auxerre, France
- CHU de Bordeaux — Bourdeaux, France
- CHRU de Brest — Brest, France
- CHU de Caen — Caen, France
- Hôpital Lyon Sud — Lyon, France
- Hôpital Saint Joseph Saint Luc — Lyon, France
- Institut Phocéen de Néphrologie - Clinique Bouchard — Marseille, France
- CH de Niort — Niort, France
Full record on ClinicalTrials.gov
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