Rheopheresis as an add-on treatment for calciphylaxis in people on hemodialysis
Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial
This trial will try adding rheopheresis to usual care to see if it helps people on hemodialysis with ulcerated or necrotic calciphylaxis skin lesions heal and improve symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 29 sites (Angers and 28 other locations) |
| Trial ID | NCT04654000 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled trial comparing rheopheresis added to standard care versus standard care with sham-apheresis in patients with ulcerated or necrotic calciphylaxis on hemodialysis. Rheopheresis is a double-filtration plasmapheresis that removes selected high–molecular-weight plasma proteins linked to vascular inflammation and thrombosis. Participants meeting inclusion criteria will be randomized to receive active rheopheresis procedures or sham procedures in addition to usual multidisciplinary management. The trial will monitor safety and clinical outcomes such as lesion healing, pain, and progression over a defined follow-up period.
Who should consider this trial
Good fit: Ideal candidates are adults with end-stage renal disease on hemodialysis who have at least one ulcerated or necrotic calciphylaxis lesion, weigh more than 30 kg, and can give informed consent.
Not a fit: Patients with very limited life expectancy (<6 months), uncontrolled infection, albumin allergy, inability to stop certain anticoagulants, severe cognitive impairment, or pregnancy are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, adding rheopheresis could speed healing of skin lesions, reduce pain and complications, and improve outcomes for dialysis patients with calciphylaxis.
How similar studies have performed: Rheopheresis has prior use in other microcirculatory disorders, but randomized evidence specifically for calciphylaxis is very limited and this application is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Angers and 28 other locations
- CHU d'Angers — Angers, France (Not_yet_recruiting)
- CHU d'Arras — Arras, France (Recruiting)
- CHU d'Auxerre — Auxerre, France (Not_yet_recruiting)
- CHU de Besançon, Hôpital Jean Minjoz — Besançon, France (Recruiting)
- CH de Béthune — Béthune, France (Recruiting)
- CH de Boulogne sur Mer — Boulogne-sur-Mer, France (Recruiting)
- CHU de Bordeaux — Bourdeaux, France (Not_yet_recruiting)
- CHRU de Brest — Brest, France (Not_yet_recruiting)
- CHU de Caen — Caen, France (Not_yet_recruiting)
- Hôpital Nord Michallon, CHU de Grenoble — Grenoble, France (Recruiting)
- Centre ECHO Laval — Laval, France (Recruiting)
- Centre ECHO Le Mans — Le Mans, France (Recruiting)
- Hôpital Privé La Louvière — Lille, France (Recruiting)
- Hop Claude Huriez Chu Lille — Lille, France (Recruiting)
- CHR de Limoges — Limoges, France (Recruiting)
- Hôpital Lyon Sud — Lyon, France (Not_yet_recruiting)
- Hôpital Saint Joseph Saint Luc — Lyon, France (Not_yet_recruiting)
- Institut Phocéen de Néphrologie - Clinique Bouchard — Marseille, France (Not_yet_recruiting)
- Hôpital de la Conception, AP-HM — Marseille, France (Recruiting)
- CHU de Montpellier — Montpellier, France (Recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- CH de Niort — Niort, France (Not_yet_recruiting)
- CHU de Reims — Reims, France (Recruiting)
- CHU de Toulouse — Toulouse, France (Recruiting)
- Clinique Saint Exupéry — Toulouse, France (Not_yet_recruiting)
- CH de Valenciennes — Valenciennes, France (Recruiting)
- CHRU de Nancy Brabois — Vandœuvre-lès-Nancy, France (Not_yet_recruiting)
- Centre Hospitalier Bretagne Atlantique — Vannes, France (Not_yet_recruiting)
- CH de Vichy — Vichy, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Arnaud Lionet, MD — University Hospital, Lille
- Study coordinator: Arnaud Lionet, MD
- Email: arnaud.lionet@chru-lille.fr
- Phone: 0320445000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.