RecruitingNAINTERVENTIONAL

Rheopheresis as Adjuvant Treatment of Calciphylaxis

This study is investigating a treatment called rheopheresis for a serious skin condition called calciphylaxis. Calciphylaxis causes painful ulcers and is most common in people with severe kidney disease who are on dialysis. Rheopheresis is a procedure that filters the blood to remove certain large proteins that can contribute to blood vessel problems. Researchers want to compare if adding rheopheresis to standard care helps people with calciphylaxis and ulcers heal better than just receiving standard care. It's a randomised study, meaning participants will be assigned to either the rheopheresis group or a control group by chance. The goal is to find a more effective way to treat this rare condition.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Lille

Enrolment target

138

Start

07 Mar 2023

Estimated completion

01 May 2027

Metabolic Disorder End Stage Renal Disease Rare Diseases

What is this study about?

This study is about a rare but serious skin condition called calciphylaxis. If you have calciphylaxis, you develop very painful skin ulcers, which are open sores that don't heal easily. This condition is most often seen in people who have severe kidney disease and need dialysis regularly. It happens because tiny blood vessels in the skin get blocked, which stops blood from reaching the skin properly.

Doctors are looking into a treatment called rheopheresis. This treatment involves filtering your blood to remove specific proteins that are thought to contribute to the problems seen in calciphylaxis, like inflammation and blood clots in those tiny vessels. The idea is that by removing these proteins, the treatment might help blood flow better and allow the skin ulcers to heal.

This study wants to find out if adding rheopheresis to the usual care for calciphylaxis helps people heal better than just getting the usual care. They will compare two groups: one receiving rheopheresis alongside their regular treatment, and another receiving regular treatment plus a 'sham' procedure that looks like rheopheresis but doesn't actually filter the blood. This helps ensure that any benefits seen are truly from the treatment itself.

Key takeaways

Study explores a blood filtering treatment called rheopheresis.
Aims to heal painful skin ulcers from calciphylaxis.
Primarily for people with kidney failure on dialysis.
Compares new treatment to standard care plus a 'sham' procedure.
Participation is voluntary and carefully explained.

Who may be eligible?

To be considered for this study, you would typically need to have calciphylaxis with at least one ulcer or sore that is actively causing tissue damage. You must also have severe kidney disease that requires regular dialysis. You should weigh more than 30 kilograms (about 4 stone 10 pounds) and be part of a social security system.

There are several reasons why someone might not be able to join. For example, if your general health or life expectancy is very low, or if you have an uncontrolled infection or certain other medical conditions like a severe allergy to albumin (a protein used in the treatment). You also wouldn't be able to participate if you are pregnant or breastfeeding, have severe thinking or mental health problems that prevent you from understanding the study, or if you are unable or unwilling to give your consent to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have calciphylaxis with open sores or damaged skin?
Do you have severe kidney disease and receive dialysis?
Do you weigh more than 30 kilograms (around 4 stone 10 pounds)?
Are you able to understand and agree to participate in a study?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly assigned to one of two groups: either the group receiving rheopheresis treatment alongside your usual care, or a group receiving a 'sham' procedure (which looks like rheopheresis but doesn't filter the blood) alongside your usual care. Both rheopheresis and the sham procedure involve having tubes placed into your veins to filter your blood. The doctors will monitor your ulcers and overall health closely throughout the study to see how you respond. The total duration of your participation in the study, including follow-up, would be fully explained by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit if rheopheresis proves to be an effective treatment for calciphylaxis, possibly leading to better healing of your skin ulcers. However, there are potential risks associated with any medical procedure, including rheopheresis, such as discomfort, infection or bruising where needles are inserted, or reactions to the blood filtering process. The doctors and nurses will explain all potential risks in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (29)

CHU d'Angers
Verified postcode
Angers, France· Not yet recruiting
CHU d'Arras
Verified postcode
Arras, France· Recruiting
CHU d'Auxerre
Verified postcode
Auxerre, France· Not yet recruiting
CHU de Besançon, Hôpital Jean Minjoz
Verified postcode
Besançon, France· Recruiting
CH de Béthune
Verified postcode
Béthune, France· Recruiting
CH de Boulogne sur Mer
Verified postcode
Boulogne-sur-Mer, France· Recruiting
CHU de Bordeaux
Verified postcode
Bourdeaux, France· Not yet recruiting
CHRU de Brest
Verified postcode
Brest, France· Not yet recruiting
CHU de Caen
Verified postcode
Caen, France· Not yet recruiting
Hôpital Nord Michallon, CHU de Grenoble
Verified postcode
Grenoble, France· Recruiting
Centre ECHO Laval
Verified postcode
Laval, France· Recruiting
Centre ECHO Le Mans
Verified postcode
Le Mans, France· Recruiting

Common questions

What is calciphylaxis?

It's a rare, serious skin condition causing painful ulcers, often in people with severe kidney disease.

What is rheopheresis?

It's a blood filtering treatment that removes certain large proteins from your blood to help improve circulation.

Will I definitely get the new treatment?

No, you'll be randomly assigned to either receive the new treatment or a 'sham' procedure to compare effectiveness.

Will I still get my usual care?

Yes, all participants in the study will continue to receive their standard medical care for calciphylaxis.

Can I stop participating if I want to?

Yes, you can leave the study at any time without it affecting your ongoing medical treatment.

How to find out more

Arnaud Lionet, MD

arnaud.lionet@chru-lille.fr 0320445000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.