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NCT05633121: RHEO-CUA

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

Completed Last updated 7 December 2023
What this trial tests

trial testing Rheopheresis in Rheopheresis in 55 participants. Completed in 30 September 2023.

Timeline
20 May 2021
Primary endpoint
31 December 2022
30 September 2023

Quick facts

Lead sponsorAssociation ECHO
StatusCompleted
Study typeOBSERVATIONAL
Enrollment55
Start date20 May 2021
Primary completion31 December 2022
Estimated completion30 September 2023
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Association ECHO

Who can join

18 and older, any sex, with Rheopheresis or Calcifying Uremic Arteriolopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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