Rheopheresis as Adjuvant Treatment of Calciphylaxis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Rheopheresis procedure
- Sham-apheresis
Treatment groups
138 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Lille
Lead sponsor
Direction Générale de l'Offre de Soins
Collaborator
Source ClinicalTrials.gov