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Completed

NCT Number: NCT05633121

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ECHO - Pole Santé Sud

Le Mans, 72000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Proportion of patients fully recovered 6 months after diagnosis.

    Time frame: 6 months

    Complete healing will be defined by the healing of all skin lesions without the appearance of new ones.

Sponsors and collaborators

Lead sponsor

Association ECHO

Other

Collaborators

  • Elsan
  • European Clinical Trial Experts Network

Registry information

Official study title

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

Acronym: RHEO-CUA

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 1, 2022
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.