RheopheresisRHEO-CUANCT05633121
Retrospective Study Evaluating the Contribution of Rheopheresis in the Treatment of Uremic Calciphylaxis (RHEO-CUA)
An observational study of Rheopheresis and Calcifying Uremic Arteriolopathy, run by Association ECHO at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheopheresis, Calcifying Uremic Arteriolopathy, Uremic Calciphylaxis
- What is being tested?
- Rheopheresis
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2021to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient on chronic hemodialysis and suffering from uraemic calciphylaxis.
Who may be able to join
- 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.
Who cannot join
- minor patient,
- Advanced cognitive disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study Evaluating the Contribution of Rheopheresis in the Treatment of Uremic Calciphylaxis
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.
- Being tested
- Rheopheresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RheopheresisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient suffering from uremic calciphylaxis treated with rheopheresis | Not described Receives: Procedure: Rheopheresis | |
| Patient suffering from uremic calciphylaxis not treated with rheopheresis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start20 May 2021
- Primary completion31 Dec 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RheopheresisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association ECHO
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network, Elsan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633121
- Sponsor's protocol ID
- RHEO-CUA
- Acronym
- RHEO-CUA
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study Evaluating the Contribution of Rheopheresis in the Treatment of Uremic Calciphylaxis
- ClinicalTrials.gov ID
- NCT05633121
- Acronym / sponsor ID
- RHEO-CUA / RHEO-CUA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Association ECHOUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network, Elsan
- Study start
- 20 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient suffering from uremic calciphylaxis treated with rheopheresis | – | Procedure: Rheopheresis |
| Patient suffering from uremic calciphylaxis not treated with rheopheresis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient on chronic hemodialysis and suffering from uraemic calciphylaxis.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- minor patient,
- Advanced cognitive disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RheopheresisTechnique 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. | Procedure or surgery | Patient suffering from uremic calciphylaxis treated with rheopheresis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
Related trials for Rheopheresis
Recruiting
Rheopheresis as Adjuvant Treatment of Calciphylaxis
Metabolic Disorder, End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheopheresis and Calcifying Uremic Arteriolopathy, run by Association ECHO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients fully recovered 6 months after diagnosis. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.