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Blood filtering may heal rare skin wounds in kidney patients

NCT ID NCT04654000

Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a blood filtering procedure called rheopheresis to treat calciphylaxis, a rare condition causing painful skin wounds in people on dialysis. About 138 participants will receive either rheopheresis or a sham procedure to see if it helps wounds heal completely within 12 weeks. The goal is to find a better way to manage this serious complication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rheopheresis procedure (a blood filtering treatment)
What this could lead to
If it works, this could offer a new way to help heal painful skin wounds in dialysis patients with calciphylaxis, improving their quality of life.
What could go wrong
This is a small, early-stage trial with only 138 participants. The treatment is complex and may not work for everyone, and there are risks from the procedure itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 138 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Calciphylaxis with at least one ulcerated or necrotizing lesion * End stage renal disease requiring hemodialysis * Weight superior to 30kg * Subject affiliated to or beneficiary of a social security system * Subject having signed written informed consent A patient with progressing calciphylaxis to ulcerate or necrosis despite conventional treatment may also be included. Exclusion Criteria: * KARNOFSKY Performance Status Scale inferior to 30% * Life expectancy (independently of calciphylaxis) estimated \< 6 months according to a referring physician expert in hemodialysis * Uncontrolled infection (persistence of fever despite appropriate antibiotic therapy) * Common variable immunodeficiency * Albumin allergy * Contra-indication to stop anti-vitamin K treatment * Severe cognitive or psychiatric disorders, patients unable to give an informed consent or unwilling to participate in the study * Pregnancy or breastfeeding and all the other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without contentment, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations.

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Conditions

The condition(s) this trial relates to.

calciphylaxis chronic kidney disease chronic renal failure syndrome end stage renal failure metabolic disease Rare Diseases

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End-stage renal disease Metabolic disorder Rare diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH de Boulogne sur Mer

    RECRUITING

    Boulogne-sur-Mer, 62321, France

  • CH de Béthune

    RECRUITING

    Béthune, 62408, France

  • CH de Niort

    NOT_YET_RECRUITING

    Niort, 79000, France

  • CH de Valenciennes

    RECRUITING

    Valenciennes, 59300, France

  • CH de Vichy

    NOT_YET_RECRUITING

    Vichy, 03200, France

  • CHR de Limoges

    RECRUITING

    Limoges, 87042, France

  • CHRU de Brest

    NOT_YET_RECRUITING

    Brest, 29609, France

  • CHRU de Nancy Brabois

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • CHU d'Angers

    NOT_YET_RECRUITING

    Angers, 49933, France

  • CHU d'Arras

    RECRUITING

    Arras, 62022, France

  • CHU d'Auxerre

    NOT_YET_RECRUITING

    Auxerre, 89011, France

  • CHU de Besançon, Hôpital Jean Minjoz

    RECRUITING

    Besançon, 25000, France

  • CHU de Bordeaux

    NOT_YET_RECRUITING

    Bourdeaux, 33076, France

  • CHU de Caen

    NOT_YET_RECRUITING

    Caen, 14033, France

  • CHU de Montpellier

    RECRUITING

    Montpellier, 34295, France

  • CHU de Nantes

    RECRUITING

    Nantes, 44093, France

  • CHU de Reims

    RECRUITING

    Reims, 51092, France

  • CHU de Toulouse

    RECRUITING

    Toulouse, 31059, France

  • Centre ECHO Laval

    RECRUITING

    Laval, 53015, France

  • Centre ECHO Le Mans

    RECRUITING

    Le Mans, 72000, France

  • Centre Hospitalier Bretagne Atlantique

    NOT_YET_RECRUITING

    Vannes, 56017, France

  • Clinique Saint Exupéry

    NOT_YET_RECRUITING

    Toulouse, 31400, France

  • Hop Claude Huriez Chu Lille

    RECRUITING

    Lille, France

  • Hôpital Lyon Sud

    NOT_YET_RECRUITING

    Lyon, 69495, France

  • Hôpital Nord Michallon, CHU de Grenoble

    RECRUITING

    Grenoble, 38043, France

  • Hôpital Privé La Louvière

    RECRUITING

    Lille, 59000, France

  • Hôpital Saint Joseph Saint Luc

    NOT_YET_RECRUITING

    Lyon, 69635, France

  • Hôpital de la Conception, AP-HM

    RECRUITING

    Marseille, 13385, France

  • Institut Phocéen de Néphrologie - Clinique Bouchard

    NOT_YET_RECRUITING

    Marseille, 13006, France

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Other studies related to the condition(s) this trial covers.