Rheopheresis as Adjuvant Treatment of Calciphylaxis
NCT04654000 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138
Last updated 2026-02-12
Summary
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.
Conditions
- Metabolic Disorder
- End Stage Renal Disease
- Rare Diseases
Interventions
- PROCEDURE
-
Rheopheresis procedure
rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins
- PROCEDURE
-
Sham-apheresis
Sham-apheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient.
Sponsors & Collaborators
-
Direction Générale de l'Offre de Soins
collaborator OTHER_GOV -
University Hospital, Lille
lead OTHER
Principal Investigators
-
Arnaud Lionet, MD · University Hospital, Lille
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-07
- Primary Completion
- 2027-04-30
- Completion
- 2027-05-31
Countries
- France
Study Locations
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