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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
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

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU d Angers
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AngersFranceNot yet recruiting
CHU d'Arras
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ArrasFranceRecruiting
CHU d'Auxerre
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AuxerreFranceNot yet recruiting
CHU de Besancon - Hopital Jean Minjoz
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BesançonFranceRecruiting
CH de Béthune
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BéthuneFranceRecruiting
CH de Boulogne-sur-Mer
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Boulogne-sur-MerFranceRecruiting
CHU de Bordeaux
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BourdeauxFranceNot yet recruiting
CHRU de Brest
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BrestFranceNot yet recruiting
CHU de CAEN
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CaenFranceNot yet recruiting
Hôpital Nord Michallon, CHU de Grenoble
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GrenobleFranceRecruiting
Centre ECHO Laval
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LavalFranceRecruiting
Centre ECHO Le Mans
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Le MansFranceRecruiting
Hop Claude Huriez Chu Lille
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LilleFranceRecruiting
Hôpital Privé La Louviere
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LilleFranceRecruiting
CHR de Limoges
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LimogesFranceRecruiting
Hopital Lyon Sud
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LyonFranceNot yet recruiting
Hôpital Saint Joseph Saint Luc
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LyonFranceNot yet recruiting
Institut Phocéen de Néphrologie - Clinique Bouchard
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MarseilleFranceNot yet recruiting
Hôpital de la Conception, AP-HM
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MarseilleFranceRecruiting
CHU de Montpellier
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MontpellierFranceRecruiting
CHU de Nantes
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NantesFranceRecruiting
CH de Niort
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NiortFranceNot yet recruiting
CHU de Reims
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ReimsFranceRecruiting
CHU de Toulouse
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ToulouseFranceRecruiting
Clinique Saint Exupéry
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ToulouseFranceNot yet recruiting
CH de Valenciennes
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ValenciennesFranceRecruiting
Chru de Nancy-Brabois
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Vandœuvre-lès-NancyFranceNot yet recruiting
Centre Hospitalier Bretagne Atlantique
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VannesFranceNot yet recruiting
CH de Vichy
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VichyFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.