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Rheopheresis as Adjuvant Treatment of Calciphylaxis (RHEO-CAL)

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ClinicalTrials.gov Identifier: NCT04654000
Recruitment Status : Not yet recruiting
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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Brief Summary:
We 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.

Condition or disease Intervention/treatment Phase
Metabolic Disorder End Stage Renal Disease Rare Diseases Procedure: Rheopheresis procedure Procedure: Sham-apheresis Not Applicable

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. We 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
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Study Type : Interventional
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : May 2025

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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). [ 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Overall survival [ Time Frame: at 12 weeks and 12 months after first rheopheresis. ]
    Survival of patients, whether or not calciphylaxis is cured.

  9. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04654000


Contacts
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Contact: Arnaud Lionet, MD 0320445000 ext +33 arnaud.lionet@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
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Principal Investigator: Arnaud Lionet, MD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04654000    
Other Study ID Numbers: 2020_05
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Calciphylaxis
Rheopheresis
Hemodialysis
Chronic kidney disease
Additional relevant MeSH terms:
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Metabolic Diseases
Rare Diseases
Kidney Diseases
Urologic Diseases
Disease Attributes
Calcium Metabolism Disorders
 Kidney Failure, Chronic
Calciphylaxis
Renal Insufficiency, Chronic
Renal Insufficiency
Pathologic Processes
Calcinosis