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

Retrospective Study Evaluating the Contribution of Rheopheresis in the Treatment of Uremic Calciphylaxis

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.

Study Overview

• Status: Completed
• Conditions: Rheopheresis; Calcifying Uremic Arteriolopathy; Uremic Calciphylaxis
• Intervention / Treatment: Procedure: Rheopheresis

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• France
  • Le Mans, France, 72000
    • ECHO - Pole Santé Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patient on chronic hemodialysis and suffering from uraemic calciphylaxis.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient suffering from uremic calciphylaxis treated with rheopheresis	Procedure: Rheopheresis; 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.
Patient suffering from uremic calciphylaxis not treated with rheopheresis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Association ECHO
• Collaborators: Elsan; European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis; Calciphylaxis
• Other Study ID Numbers: RHEO-CUA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No