Rheopheresis as Adjuvant Treatment of Calciphylaxis

NCT04654000 | Recruiting DMC

• 2 other identifiers: 2020_052020-A02896-33
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 29

Brief 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.

Conditions

Metabolic Disorder; End Stage Renal Disease; Rare Diseases

Keywords

Calciphylaxis; Rheopheresis; Hemodialysis; Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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.

  at 12 weeks of treatement

Secondary Outcomes (9)

• Percentage of patient with partial wound healing of the calciphylaxis mediated lesions after rheopheresis treatment.

  At 4 weeks and 12 weeks of rheopheresis treatment.

• Occurrence of new ulcerated calciphylaxis lesions

  At 4 weeks and 12 weeks of rheopheresis treatment.

• Evolution of the self-reporting pain using Numeric Rating Scale (NRS)

  from baseline (V0) to 12 weeks of rheopheresis (V2)

• Evolution of the level of antalgic consumed according to World Health Organisation (WHO) classification

  from baseline (V0) to 12 weeks of rheopheresis (V2)

• Number of days without antibiotics

  during the 12 weeks of rheopheresis treatment

Study Arms (2)

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).

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.

Procedure: Sham-apheresis

Interventions

Rheopheresis procedure PROCEDURE

rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins

Rheopheresis group

Sham-apheresis PROCEDURE

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.

Sham-apheresis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (29)

CHU d'Angers

Angers, 49933, France

NOT YET RECRUITING

CHU d'Arras

Arras, 62022, France

RECRUITING

CHU d'Auxerre

Auxerre, 89011, France

NOT YET RECRUITING

CHU de Besançon, Hôpital Jean Minjoz

Besançon, 25000, France

RECRUITING

CH de Béthune

Béthune, 62408, France

RECRUITING

CH de Boulogne sur Mer

Boulogne-sur-Mer, 62321, France

RECRUITING

CHU de Bordeaux

Bourdeaux, 33076, France

NOT YET RECRUITING

CHRU de Brest

Brest, 29609, France

NOT YET RECRUITING

CHU de Caen

Caen, 14033, France

NOT YET RECRUITING

Hôpital Nord Michallon, CHU de Grenoble

Grenoble, 38043, France

RECRUITING

Centre ECHO Laval

Laval, 53015, France

RECRUITING

Centre ECHO Le Mans

Le Mans, 72000, France

RECRUITING

Hôpital Privé La Louvière

Lille, 59000, France

RECRUITING

Hop Claude Huriez Chu Lille

Lille, France

RECRUITING

CHR de Limoges

Limoges, 87042, France

RECRUITING

Hôpital Lyon Sud

Lyon, 69495, France

NOT YET RECRUITING

Hôpital Saint Joseph Saint Luc

Lyon, 69635, France

NOT YET RECRUITING

Institut Phocéen de Néphrologie - Clinique Bouchard

Marseille, 13006, France

NOT YET RECRUITING

Hôpital de la Conception, AP-HM

Marseille, 13385, France

RECRUITING

CHU de Montpellier

Montpellier, 34295, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

CH de Niort

Niort, 79000, France

NOT YET RECRUITING

CHU de Reims

Reims, 51092, France

RECRUITING

CHU de Toulouse

Toulouse, 31059, France

RECRUITING

Clinique Saint Exupéry

Toulouse, 31400, France

NOT YET RECRUITING

CH de Valenciennes

Valenciennes, 59300, France

RECRUITING

CHRU de Nancy Brabois

Vandœuvre-lès-Nancy, 54500, France

NOT YET RECRUITING

Centre Hospitalier Bretagne Atlantique

Vannes, 56017, France

NOT YET RECRUITING

CH de Vichy

Vichy, 03200, France

NOT YET RECRUITING

MeSH Terms

Conditions

Metabolic Diseases; Kidney Failure, Chronic; Rare Diseases; Calciphylaxis; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcinosis; Calcium Metabolism Disorders

Study Officials

• Arnaud Lionet, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnaud Lionet, MD

CONTACT

0320445000; arnaud.lionet@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 4, 2020
• Study Start: March 7, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

FR (29)