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NCT05633121: RHEO-CUA
Retrospective Study Evaluating the Contribution of Rheopheresis in the Treatment of Uremic Calciphylaxis (RHEO-CUA)
trial testing Rheopheresis in Rheopheresis in 55 participants. Completed in 30 September 2023.
31 December 2022
Quick facts
| Lead sponsor | Association ECHO |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 55 |
| Start date | 20 May 2021 |
| Primary completion | 31 December 2022 |
| Estimated completion | 30 September 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Rheopheresis
Conditions studied
- Rheopheresis — all drugs for Rheopheresis →
- Calcifying Uremic Arteriolopathy — all drugs for Calcifying Uremic Arteriolopathy →
- Uremic Calciphylaxis — all drugs for Uremic Calciphylaxis →
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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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05633121 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Association ECHO
- Last refreshed: 7 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05633121.
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