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NCT04654000 | Not yet recruiting | Metabolic Disorder


Rheopheresis as Adjuvant Treatment of Calciphylaxis
Sponsor:

University Hospital, Lille

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

Metabolic Disorder

End Stage Renal Disease

Rare Diseases

Intervention/treatment

Rheopheresis procedure

Sham-apheresis

Phase

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 Type : Interventional
Estimated Enrollment : 138 participants
Masking: Double
Primary Purpose: Diagnostic
Official Title: Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial
Actual Study Start Date : May 2021
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : May 2025
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

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

Ages Eligible for Study: 18 Years
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.

Rheopheresis as Adjuvant Treatment of Calciphylaxis

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Rheopheresis as Adjuvant Treatment of Calciphylaxis

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