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

NCT05633121 | Completed

• 1 other identifier: RHEO-CUA
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheopheresis; Calcifying Uremic Arteriolopathy; Uremic Calciphylaxis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patient suffering from uremic calciphylaxis treated with rheopheresis

Procedure: Rheopheresis

Patient suffering from uremic calciphylaxis not treated with rheopheresis

Interventions

Rheopheresis PROCEDURE

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 treated with rheopheresis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient on chronic hemodialysis and suffering from uraemic calciphylaxis.

You may qualify if:

• 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.

You may not qualify if:

• minor patient,
• Advanced cognitive disorders.

Sponsors & Collaborators

• Association ECHO: lead
• European Clinical Trial Experts Network: collaborator
• Elsan: collaborator

Study Sites (1)

ECHO - Pole Santé Sud

Le Mans, 72000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: May 20, 2021
• Primary Completion: December 31, 2022
• Study Completion: September 30, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

FR (1)