Metabolic DisorderRHEO-CALNCT04654000
Rheopheresis as Adjuvant Treatment of Calciphylaxis
A study testing Rheopheresis procedure in people with Metabolic Disorder and End Stage Renal Disease, run by University Hospital, Lille at 29 sites in France.
Trial summary
The investigators propose to set up a prospective randomized controlled trial to control the security and assess the efficacy of adjuvant treatment by rheopheresis in necrotizing-ulcered calciphylaxis in the hemodialysis population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Disorder, End Stage Renal Disease, Rare Diseases
- What is being tested?
- Rheopheresis procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 29 sitesFrance
- Study dates
- 7 Mar 2023to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
France29 sites, 29 recruiting
- Not yet recruiting
CHU d'Angers
Angers, 49933
Anne-Sophie Garnier, Dr, 02 41 35 50 63, annesophie.garnier@chu-angers.fr
- Recruiting
CHU d'Arras
Arras, 62022
Amr EKHLAS, Dr, 03 21 21 14 40, amr.ekhlas@gh-artoisternois.fr
- Not yet recruiting
CHU d'Auxerre
Auxerre, 89011
Rachid Bourouma, Dr, 03 86 48 47 16, rbourouma@ch-auxerre.fr
- Recruiting
CHU de Besançon, Hôpital Jean Minjoz
Besançon, 25000
Thomas CREPIN, Dr, 03 81 21 82 56, tcrepin@chu-besancon.fr
- Recruiting
CH de Béthune
Béthune, 62408
Anderson RATSIMBAZAFY, Dr, 03 21 64 43 44, anderson.ratsimbazafy@ch-bethune.fr
- Recruiting
CH de Boulogne sur Mer
Boulogne-sur-Mer, 62321
Vincent Delattre, Dr, 03 21 99 88 01, v.delattre@ch-boulogne.fr
- Not yet recruiting
CHU de Bordeaux
Bourdeaux, 33076
M Yahsou Delmas, Dr, 05 56 79 58 31, yahsou.delmas@chu-bordeaux.fr
- Not yet recruiting
CHRU de Brest
Brest, 29609
Isabelle SEGALEN, Dr, 02 98 34 25 33, isabelle.segalen@chu-brest.fr
- Not yet recruiting
CHU de Caen
Caen, 14033
Patrick Henri, Dr, 02 31 27 23 43, henri-p@chu-caen.fr
- Recruiting
Hôpital Nord Michallon, CHU de Grenoble
Grenoble, 38043
Lionel ROSTAING, Pr, lrostaing@chu-grenoble.fr
- Recruiting
Centre ECHO Laval
Laval, 53015
Wael EL HAGGAN, Dr, 02 43 66 39 52, welhagga@echo-sante.com
- Recruiting
Centre ECHO Le Mans
Le Mans, 72000
Guillaume SERET, Dr, 02 43 78 38 79, gseret@echo-sante.com
- Recruiting
Hôpital Privé La Louvière
Lille, 59000
Laurence VRIGNEAUD, Dr, 03 20 15 71 31
- Recruiting
Hop Claude Huriez Chu Lille
Lille
Arnaud Lionet, Dr, 03 20 44 50 00, arnaud.lionet@chu-lille.fr
- Recruiting
CHR de Limoges
Limoges, 87042
Zhour El Ouafi, Dr, 06 80 26 75 81, zhour.elouafi@chu-limoges.fr
- Not yet recruiting
Hôpital Lyon Sud
Lyon, 69495
Caroline PELLETIER, Dr, 04 72 11 01 57, caroline.pelletier02@chu-lyon.fr
- Not yet recruiting
Hôpital Saint Joseph Saint Luc
Lyon, 69635
Cécile CHAUVET, Dr, 04 78 61 85 74, cchauvet@saintjosephsaintluc.fr
- Not yet recruiting
Institut Phocéen de Néphrologie - Clinique Bouchard
Marseille, 13006
Stanislas Bataille, Dr, 04 91 15 94 10
- Recruiting
Hôpital de la Conception, AP-HM
Marseille, 13385
Maxence TAILLIAR, Dr, 04 91 38 30 43, Maxence.Tailliar@ap-hm.fr
- Recruiting
CHU de Montpellier
Montpellier, 34295
Jean-Emmanuel Serre, Dr, 04 67 33 84 76, je-serre@chu-montpellier.fr
- Recruiting
CHU de Nantes
Nantes, 44093
Agnès CHAPELET DEBOUT, Dr, 02 40 08 74 08, agnes.chapelet@chu-nantes.fr
- Not yet recruiting
CH de Niort
Niort, 79000
Eric Moumas, Dr, 05 49 78 33 32, eric.moumas@ch-niort.fr
- Recruiting
CHU de Reims
Reims, 51092
Alain WINCKEL, Dr, awynckel@chu-reims.fr
- Recruiting
CHU de Toulouse
Toulouse, 31059
Olivier Cointault, Dr, 05 61 32 25 84, cointault.o@chu-toulouse.fr
- Not yet recruiting
Clinique Saint Exupéry
Toulouse, 31400
Damien GUINAULT, 05 61 17 32 14, damien.guinault@clinique-saint-exupery.com
- Recruiting
CH de Valenciennes
Valenciennes, 59300
Cyrille VANDENBUSSCHE, Dr, 03 27 14 30 89, vandenbussche-c@ch-valenciennes.fr
- Not yet recruiting
CHRU de Nancy Brabois
Vandœuvre-lès-Nancy, 54500
Asma Alla, Dr, 03 83 15 31 64, a.alla@chru-nancy.fr
- Not yet recruiting
Centre Hospitalier Bretagne Atlantique
Vannes, 56017
Hugoline BOULAY, Dr, hugoline.boulaycorson@ch-bretagne-atlantique.fr
- Not yet recruiting
CH de Vichy
Vichy, 03200
Julie Albaret, Dr, 04 70 97 33 56, julie.albaret@ch-vichy.fr
About this study
Official title: Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial
The investigators propose to set up a prospective randomized controlled trial to control the security and assess the efficacy of adjuvant treatment by rheopheresis in necrotizing-ulcered calciphylaxis in the hemodialysis population.
Read the detailed description
Calciphylaxis, also known as uremic calcifying arteriolopathy (UCA), is a rare disease that causes painful ischemic skin lesions due to microvascular calcification and thrombosis of the dermis and subcutaneous adipose tissue. Patients with end-stage renal disease (ESRD) are the main target for calciphylaxis. Rheopheresis is a therapeutic apheresis to treat microcirculatory disorders. This double filtration plasmapheresis eliminates a defined spectrum of high molecular weight proteins from human plasma including relevant factors for vascular inflammation and thrombose. The investigators propose a prospective randomized controlled trial to compared the efficacy of rheopheresis as adjuvant treatment to the standard of care compared to standard care with Sham-apheresis.
- Conditions
- Metabolic Disorder, End Stage Renal Disease, Rare Diseases
- Being tested
- Rheopheresis procedure, Sham-apheresis
- Keywords
- Calciphylaxis, Rheopheresis, Hemodialysis, Chronic kidney disease
- Medical subject headings
- Metabolic Diseases, Kidney Failure, Chronic, Rare Diseases, Calciphylaxis, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheopheresis procedureProcedure or surgery
rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins
Sham-apheresisProcedure or surgery
Sham-apheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Rheopheresis group | Experimental | In addition to the standards of care, the experimental group will carry out the rheopheresis in two stages:
* Stage 1: induction treatment: 3 apheresis sessions during the first week (w0; i.e. between D1 and D7) and then 2 apheresis sessions each week for 3 weeks (from w1 to w3; i.e. between D8 and D28) ;
* Step 2: maintenance treatment with 1 apheresis session per week until the 11th week (i.e. between D29 and D84). Receives: Procedure: Rheopheresis procedure |
| Sham-apheresis group | Sham comparator | In addition to the standards of care, the comparator group will carry out Sham-apheresis sessions according to the same scheme as the rheopheresis sessions of the experimental group. Receives: Procedure: Sham-apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete wound healing of the calciphylaxis-mediated ischemic lesions after 12 weeks of rheopheresis treatment (a total of 17 sessions).
Complete wound healing is defined as the absence of livedoid peri-lesional inflammation with presence of granulation tissue (stage 3 healing process) and/or epithelization (stage 4) over the entire ulcer surface of calciphylactic lesions. The healing of the lesions will be illustrated with a photographic support. And the pictures will be examined a second time in a centralized and blind way by two referring dermatologists.
In case of multiple calciphylaxis skin lesions, monitoring and evaluation will be done on the largest lesion at the time of patient's inclusion.
Measured: at 12 weeks of treatement
Secondary outcomes (9)
Percentage of patient with partial wound healing of the calciphylaxis mediated lesions after rheopheresis treatment.
The partial healing is defined by a partial reepithelialization (validated if 3 of following 4 criteria are present: 1-absence of necrosis; 2- granulation; 3 less inflammatory bordering 4- 20% decrease of the lesion size). The evolution of the size of the lesions and the partial healing of the wound will be illustrated by a photographic support.
Measured: At 4 weeks and 12 weeks of rheopheresis treatment.
Occurrence of new ulcerated calciphylaxis lesions
Occurrence of new ulcerated calciphyalxis lesions frome Baseline to 4 and 12 weeks of treatment.
Measured: At 4 weeks and 12 weeks of rheopheresis treatment.
Evolution of the self-reporting pain using Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS) describes the pain intensity at 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme
Measured: from baseline (V0) to 12 weeks of rheopheresis (V2)
Evolution of the level of antalgic consumed according to World Health Organisation (WHO) classification
The level of consumed antalgic is defined according to the World Health Organization (WHO) classification
- Level I analgesics = peripheral analgesics or not morphine have the lowest analgesic power
- Level II analgesics = weak morphine.
- Level III analgesics = strong morphine agonists and antagonists.
Measured: from baseline (V0) to 12 weeks of rheopheresis (V2)
Number of days without antibiotics
Number of days the patient receives antibiotics, regardless of the route of administration, whether the patient is treated on an outpatient or inpatient basis.
Measured: during the 12 weeks of rheopheresis treatment
Quality of life by the Wound quality of life score (Wound-Qol)
The Wound-QoL measures the disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which are always assessed in retrospect to the preceding seven days.
Measured: form baseline (V0) and at 12 weeks
Number of days discharged from hospital
Number of days the patient is treated on an outpatient basis.
Measured: during the 12 weeks of rheopheresis treatment
Overall survival
Survival of patients, whether or not calciphylaxis is cured.
Measured: at 12 weeks and 12 months after first rheopheresis.
Change in inflammatory proteins
Change in the plasmatic rates of C-reactive protein (CRP) and fibrinogen.
Measured: from baseline to 12 weeks-rheopheresis treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start7 Mar 2023
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Arnaud Lionet, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654000
- Sponsor's protocol ID
- 2020_05
- Other IDs
- 2020-A02896-33
- Acronym
- RHEO-CAL
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2020
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial
- ClinicalTrials.gov ID
- NCT04654000
- Acronym / sponsor ID
- RHEO-CAL / 2020_05
- Conditions
- Metabolic Disorder, End Stage Renal Disease, Rare Diseases
- Keywords
- Calciphylaxis, Rheopheresis, Hemodialysis, Chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Dec 2020 (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.
The investigators propose to set up a prospective randomized controlled trial to control the security and assess the efficacy of adjuvant treatment by rheopheresis in necrotizing-ulcered calciphylaxis in the hemodialysis population.
Detailed description
Calciphylaxis, also known as uremic calcifying arteriolopathy (UCA), is a rare disease that causes painful ischemic skin lesions due to microvascular calcification and thrombosis of the dermis and subcutaneous adipose tissue. Patients with end-stage renal disease (ESRD) are the main target for calciphylaxis. Rheopheresis is a therapeutic apheresis to treat microcirculatory disorders. This double filtration plasmapheresis eliminates a defined spectrum of high molecular weight proteins from human plasma including relevant factors for vascular inflammation and thrombose. The investigators propose a prospective randomized controlled trial to compared the efficacy of rheopheresis as adjuvant treatment to the standard of care compared to standard care with Sham-apheresis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheopheresis group | Experimental | Procedure: Rheopheresis procedureIn addition to the standards of care, the experimental group will carry out the rheopheresis in two stages: * Stage 1: induction treatment: 3 apheresis sessions during the first week (w0; i.e. between D1 and D7) and then 2 apheresis sessions each week for 3 weeks (from w1 to w3; i.e. between D8 and D28) ; * Step 2: maintenance treatment with 1 apheresis session per week until the 11th week (i.e. between D29 and D84). |
| Sham-apheresis group | Sham comparator | Procedure: Sham-apheresisIn addition to the standards of care, the comparator group will carry out Sham-apheresis sessions according to the same scheme as the rheopheresis sessions of the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Rheopheresis procedurerheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins | Procedure or surgery | Rheopheresis group |
| Sham-apheresisSham-apheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient. | Procedure or surgery | Sham-apheresis group |
Primary outcome
Percentage of patients with complete wound healing of the calciphylaxis-mediated ischemic lesions after 12 weeks of rheopheresis treatment (a total of 17 sessions).
Time frame: at 12 weeks of treatement
Complete wound healing is defined as the absence of livedoid peri-lesional inflammation with presence of granulation tissue (stage 3 healing process) and/or epithelization (stage 4) over the entire ulcer surface of calciphylactic lesions. The healing of the lesions will be illustrated with a photographic support. And the pictures will be examined a second time in a centralized and blind way by two referring dermatologists. In case of multiple calciphylaxis skin lesions, monitoring and evaluation will be done on the largest lesion at the time of patient's inclusion.
9 secondary outcomes
Percentage of patient with partial wound healing of the calciphylaxis mediated lesions after rheopheresis treatment.
Time frame: At 4 weeks and 12 weeks of rheopheresis treatment.
Occurrence of new ulcerated calciphylaxis lesions
Time frame: At 4 weeks and 12 weeks of rheopheresis treatment.
Evolution of the self-reporting pain using Numeric Rating Scale (NRS)
Time frame: from baseline (V0) to 12 weeks of rheopheresis (V2)
Evolution of the level of antalgic consumed according to World Health Organisation (WHO) classification
Time frame: from baseline (V0) to 12 weeks of rheopheresis (V2)
Number of days without antibiotics
Time frame: during the 12 weeks of rheopheresis treatment
Quality of life by the Wound quality of life score (Wound-Qol)
Time frame: form baseline (V0) and at 12 weeks
Number of days discharged from hospital
Time frame: during the 12 weeks of rheopheresis treatment
Overall survival
Time frame: at 12 weeks and 12 months after first rheopheresis.
Change in inflammatory proteins
Time frame: from baseline to 12 weeks-rheopheresis treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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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.
Arnaud Lionet, MD principal investigator
University Hospital, Lille
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rheopheresis procedure in people with Metabolic Disorder and End Stage Renal Disease, run by University Hospital, Lille at 29 sites 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Lionet, MD (0320445000 ext. +33, arnaud.lionet@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with complete wound healing of the calciphylaxis-mediated ischemic lesions after 12 weeks of rheopheresis treatment (a total of 17 sessions). (time frame: at 12 weeks of treatement). 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 12 Feb 2026.