An observational study in Rheopheresis, Calcifying Uremic Arteriolopathy and Uremic Calciphylaxis, sponsored by Association ECHO. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-07.
Sponsored by Association ECHO · Observational
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.
23 studies on the registry are indexed under Calciphylaxis; 10 are open to participants now.
This study's enrollment of 55 is below the median of 450 across 10 observational studies indexed under Calciphylaxis.
Browse Calciphylaxis studies →This is the only study on the registry with Association ECHO as lead sponsor.
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Adult patient on chronic hemodialysis and suffering from uraemic calciphylaxis.
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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.
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.
Time frame: 6 months
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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