Rheopheresis as Adjuvant Treatment of Calciphylaxis

Sponsor
University Hospital, Lille
Study ID
NCT04654000
Status
Recruiting
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Conditions

  • End Stage Renal Disease
  • Metabolic Disorder
  • Rare Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rheopheresis procedure — PROCEDURE
    rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins
  • Sham-apheresis — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Dec 4, 2020
Start date
Mar 7, 2023
Status verified
Feb 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Rheopheresis group
    In addition to the standards of care, the experimental group will carry out the rheopheresis in two stages: * Stage 1: induction treatment: 3 apheresis sessions during the first week (w0; i.e. between D1 and D7) and then 2 apheresis sessions each week for 3 weeks (from w1 to w3; i.e. between D8 and D28) ; * Step 2: maintenance treatment with 1 apheresis session per week until the 11th week (i.e. between D29 and D84).
  • Sham Comparator: Sham-apheresis group
    In addition to the standards of care, the comparator group will carry out Sham-apheresis sessions according to the same scheme as the rheopheresis sessions of the experimental group.

Primary Outcome Measure

Percentage of patients with complete wound healing of the calciphylaxis-mediated ischemic lesions after 12 weeks of rheopheresis treatment (a total of 17 sessions). [ Time Frame: at 12 weeks of treatement ]

Central Contacts

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