Rheopheresis as Adjuvant Treatment of Calciphylaxis (RHEO-CAL)

University Hospital, Lille

Status: Invitation-only

Conditions: Metabolic Disorder; End Stage Renal Disease; Rare Diseases

Treatments: Procedure: Rheopheresis procedure; Procedure: Sham-apheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT04654000

2020_05

2020-A02896-33 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups

Rheopheresis group

Experimental group

Description:

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).

Treatment:

Procedure: Rheopheresis procedure

Sham-apheresis group

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham-apheresis