University Hospital, Lille
We 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.
Metabolic Disorder
End Stage Renal Disease
Rare Diseases
Rheopheresis procedure
Sham-apheresis
Not Applicable
Calciphylaxis, also known as uremic calcifying arteriolopathy (UCA), is a rare disease that causes painful ischemic skin lesions due to microvascular calcification and thrombosis of the dermis and subcutaneous adipose tissue. Patients with end-stage renal disease (ESRD) are the main target for calciphylaxis. Rheopheresis is a therapeutic apheresis to treat microcirculatory disorders. This double filtration plasmapheresis eliminates a defined spectrum of high molecular weight proteins from human plasma including relevant factors for vascular inflammation and thrombose. We propose a prospective randomized controlled trial to compared the efficacy of rheopheresis as adjuvant treatment to the standard of care compared to standard care with Sham-apheresis.}}
Study Type : | Interventional |
Estimated Enrollment : | 138 participants |
Masking : | Double |
Primary Purpose : | Diagnostic |
Official Title : | Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controlled Single-blind Trial |
Actual Study Start Date : | May 2023 |
Estimated Primary Completion Date : | April 2027 |
Estimated Study Completion Date : | May 2027 |
Arm | Intervention/treatment |
---|---|
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). |
Procedure: Rheopheresis procedure |
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. |
Procedure: Sham-apheresis |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Hop Claude Huriez Chu Lille
Lille, France,