Retrospective Study Evaluating the Contribution of Rheopheresis in the Treatment of Uremic Calciphylaxis (RHEO-CUA)

Completed

• Conditions: Uremic Calciphylaxis; Calcifying Uremic Arteriolopathy; Rheopheresis
• Interventions: Procedure: Rheopheresis

• Registration Number: NCT05633121
• Lead Sponsor: Association ECHO

Brief Summary

Calcifying uremic arteriolopathy (or uremic calciphylaxis) is a rare disease (prevalence \<1% of dialysis patients), but the prognosis is often catastrophic. The main non-modifiable risk factors are age, female gender, diabetes, obesity and length of time on dialysis. Today, there is no specific treatment for this pathology, and the therapeutic management is poorly codified. However, it is commonly accepted that the treatment is based on the control of risk factors, local care, and the possible addition of treatment with sodium thiosulfate. Hyperbaric oxygen therapy has also been proposed by some authors, but remains not very accessible in practice.

Recently, it has been proposed to use Rheopheresis as an adjuvant treatment for severe forms of uraemic calciphylaxis. It is a technique of apheresis in double filtration, allowing the extraction of molecules of high molecular weight, and thus the improvement of the rheological conditions of microcirculation. The expected effect is the improvement of tissue oxygenation and the acceleration of the healing of skin lesions, with the consequent reduction of infectious complications.

The aim of this study is to propose a large national retrospective study, studying the evolution of patients with uremic calciphylaxis and treated by rheopheresis, compared to a control group. This will allow to have a more precise idea of the contribution of Rheopheresis in this indication.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-12-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-09-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Adult patient
• Chronic hemodialysis
• Uraemic calciphylaxis (clinical or histological diagnosis) diagnosed between January 2010 and December 2022,
• Rheopheresis treatment initiated within one month of calciphylaxis diagnosis (for the exposed group)
• Patient informed and not opposed to the use of their health data.

Exclusion Criteria

• minor patient,
• Advanced cognitive disorders.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient suffering from uremic calciphylaxis treated with rheopheresis	Rheopheresis	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients fully recovered 6 months after diagnosis.	6 months	Complete healing will be defined by the healing of all skin lesions without the appearance of new ones.

Trial Locations

Locations (1)

ECHO - Pole Santé Sud; 🇫🇷 Le Mans, France