NCT04654000Recruiting
Rheopheresis as Adjuvant Treatment of Calciphylaxis
Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 2 Dec 2020
- Start date
- 7 Mar 2023
- Primary completion date
- Apr 2027
- Lead sponsor
- University Hospital, Lille
- Diseases
- Chronic kidney disease
- NCT number
- NCT04654000
What you commit to
- Study type: Interventional
- Planned participants: 138
- From 7 Mar 2023 to the primary completion date, Apr 2027
- 29 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled infection (persistence of fever despite appropriate antibiotic therapy)
- Severe cognitive or psychiatric disorders, patients unable to give an informed consent or unwilling to participate in the study
Lab values
- Albumin allergy
Other
- KARNOFSKY Performance Status Scale inferior to 30%
- Life expectancy (independently of calciphylaxis) estimated \< 6 months according to a referring physician expert in hemodialysis
- Common variable immunodeficiency
- Contra-indication to stop anti-vitamin K treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU d Angers Coordinator of this site? Confirm its status | Angers | France | Not yet recruiting |
| CHU d'Arras Coordinator of this site? Confirm its status | Arras | France | Recruiting |
| CHU d'Auxerre Coordinator of this site? Confirm its status | Auxerre | France | Not yet recruiting |
| CHU de Besancon - Hopital Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| CH de Béthune Coordinator of this site? Confirm its status | Béthune | France | Recruiting |
| CH de Boulogne-sur-Mer Coordinator of this site? Confirm its status | Boulogne-sur-Mer | France | Recruiting |
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bourdeaux | France | Not yet recruiting |
| CHRU de Brest Coordinator of this site? Confirm its status | Brest | France | Not yet recruiting |
| CHU de CAEN Coordinator of this site? Confirm its status | Caen | France | Not yet recruiting |
| Hôpital Nord Michallon, CHU de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| Centre ECHO Laval Coordinator of this site? Confirm its status | Laval | France | Recruiting |
| Centre ECHO Le Mans Coordinator of this site? Confirm its status | Le Mans | France | Recruiting |
| Hop Claude Huriez Chu Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Hôpital Privé La Louviere Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHR de Limoges Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Hopital Lyon Sud Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Hôpital Saint Joseph Saint Luc Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Institut Phocéen de Néphrologie - Clinique Bouchard Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Hôpital de la Conception, AP-HM Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| CH de Niort Coordinator of this site? Confirm its status | Niort | France | Not yet recruiting |
| CHU de Reims Coordinator of this site? Confirm its status | Reims | France | Recruiting |
| CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Clinique Saint Exupéry Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| CH de Valenciennes Coordinator of this site? Confirm its status | Valenciennes | France | Recruiting |
| Chru de Nancy-Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Not yet recruiting |
| Centre Hospitalier Bretagne Atlantique Coordinator of this site? Confirm its status | Vannes | France | Not yet recruiting |
| CH de Vichy Coordinator of this site? Confirm its status | Vichy | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.