NCT04654000

Rheopheresis as Adjuvant Treatment of Calciphylaxis

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. The investigators 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.

Conditions

• Metabolic Disorder
• End Stage Renal Disease
• Rare Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-07
• Primary completion: 2027-04-01
• Completion: 2027-05-01
• First posted: 2020-12-04
• Last updated: 2026-02-12

Locations

29 sites across 1 country: France