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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05633121
Acronym
RHEO-CUA
Enrollment
55
Registered
2022-12-01
Start date
2021-05-20
Completion date
2023-09-30
Last updated
2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcifying Uremic Arteriolopathy, Rheopheresis, Uremic Calciphylaxis

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.

Interventions

PROCEDURERheopheresis

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.

Sponsors

European Clinical Trial Experts Network
CollaboratorOTHER
Elsan
CollaboratorOTHER
Association ECHO
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients fully recovered 6 months after diagnosis.6 monthsComplete healing will be defined by the healing of all skin lesions without the appearance of new ones.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026