Rheopheresis as Adjuvant Treatment of Calciphylaxis (RHEO-CAL)

February 9, 2026 updated by: University Hospital, Lille

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49933
      • Arras, France, 62022
      • Auxerre, France, 89011
        • Not yet recruiting
        • CHU d'Auxerre
        • Contact:
      • Besançon, France, 25000
        • Recruiting
        • CHU de Besançon, Hôpital Jean Minjoz
        • Contact:
      • Boulogne-sur-Mer, France, 62321
        • Recruiting
        • CH de Boulogne sur mer
        • Contact:
      • Bourdeaux, France, 33076
      • Brest, France, 29609
      • Béthune, France, 62408
      • Caen, France, 14033
        • Not yet recruiting
        • CHU de Caen
        • Contact:
      • Grenoble, France, 38043
      • Laval, France, 53015
        • Recruiting
        • Centre ECHO Laval
        • Contact:
      • Le Mans, France, 72000
        • Recruiting
        • Centre ECHO Le Mans
        • Contact:
      • Lille, France
        • Recruiting
        • Hop Claude Huriez Chu Lille
        • Contact:
      • Lille, France, 59000
        • Recruiting
        • Hôpital privé La Louvière
        • Contact:
          • Laurence VRIGNEAUD, Dr
          • Phone Number: 03 20 15 71 31
      • Limoges, France, 87042
      • Lyon, France, 69495
      • Lyon, France, 69635
      • Marseille, France, 13006
        • Not yet recruiting
        • Institut Phocéen de Néphrologie - Clinique Bouchard
        • Contact:
          • Stanislas Bataille, Dr
          • Phone Number: 04 91 15 94 10
      • Marseille, France, 13385
        • Recruiting
        • Hôpital de la Conception, AP-HM
        • Contact:
      • Montpellier, France, 34295
      • Nantes, France, 44093
      • Niort, France, 79000
        • Not yet recruiting
        • CH de Niort
        • Contact:
      • Reims, France, 51092
      • Toulouse, France, 31059
      • Toulouse, France, 31400
      • Valenciennes, France, 59300
      • Vandœuvre-lès-Nancy, France, 54500
        • Not yet recruiting
        • CHRU de Nancy Brabois
        • Contact:
      • Vannes, France, 56017
      • Vichy, France, 03200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rheopheresis group

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 12 weeks of treatement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Occurrence of new ulcerated calciphyalxis lesions frome Baseline to 4 and 12 weeks of treatment.
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)
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
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)

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.
from baseline (V0) to 12 weeks of rheopheresis (V2)
Number of days without antibiotics
Time Frame: during the 12 weeks of rheopheresis treatment
Number of days the patient receives antibiotics, regardless of the route of administration, whether the patient is treated on an outpatient or inpatient basis.
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
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.
form baseline (V0) and at 12 weeks
Number of days discharged from hospital
Time Frame: during the 12 weeks of rheopheresis treatment
Number of days the patient is treated on an outpatient basis.
during the 12 weeks of rheopheresis treatment
Overall survival
Time Frame: at 12 weeks and 12 months after first rheopheresis.
Survival of patients, whether or not calciphylaxis is cured.
at 12 weeks and 12 months after first rheopheresis.
Change in inflammatory proteins
Time Frame: from baseline to 12 weeks-rheopheresis treatment
Change in the plasmatic rates of C-reactive protein (CRP) and fibrinogen.
from baseline to 12 weeks-rheopheresis treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Direction Générale de l'Offre de Soins

Investigators

  • Principal Investigator: Arnaud Lionet, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_05
  • 2020-A02896-33 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease

Clinical Trials on Rheopheresis procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe