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Rheopheresis as Adjuvant Treatment of Calciphylaxis — RHEO-CAL  

End Stage Renal Disease Clinical Trial

Official title:
Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04654000
Study type Interventional
Source University Hospital, Lille
Contact
Status Enrolling by invitation
Phase N/A
Start date May 2023
Completion date May 2027
View Details
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