Rheopheresis as Adjuvant Treatment of Calciphylaxis

NCT04654000 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2026-02-12

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04654000 on ClinicalTrials.gov