An interventional study of Rheopheresis procedure and Sham-apheresis in Metabolic Disorder, End Stage Renal Disease and Rare Diseases, sponsored by University Hospital, Lille. Recruiting at 29 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Diagnostic
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.
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.
23 studies on the registry are indexed under Calciphylaxis; 10 are open to participants now.
This study's planned enrollment of 138 is above the median of 28 across 12 interventional studies indexed under Calciphylaxis.
Browse Calciphylaxis studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
Compared within Calciphylaxis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Metabolic Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A patient with progressing calciphylaxis to ulcerate or necrosis despite conventional treatment may also be included.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins
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.
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.
Time frame: at 12 weeks of treatement
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.
Time frame: 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.
Time frame: 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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: form baseline (V0) and at 12 weeks
Number of days discharged from hospital
Number of days the patient is treated on an outpatient basis.
Time frame: during the 12 weeks of rheopheresis treatment
Overall survival
Survival of patients, whether or not calciphylaxis is cured.
Time frame: 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.
Time frame: from baseline to 12 weeks-rheopheresis treatment
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