Clinical trial NCT04654000: Rheopheresis as Adjuvant Treatment of Calciphylaxis
Official title: Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Metabolic Disorder
End Stage Renal Disease
Rare Diseases
Keywords: Calciphylaxis
Rheopheresis
Hemodialysis
Chronic kidney disease
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2020-12-04
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of patients with complete wound healing of the calciphylaxis-mediated ischemic lesions after 12 weeks of rheopheresis treatment (a total of 17 sessions).
timeFrame: at 12 weeks of treatement
Secondary outcomes:
measure: Percentage of patient with partial wound healing of the calciphylaxis mediated lesions after rheopheresis treatment.
timeFrame: At 4 weeks and 12 weeks of rheopheresis treatment.
measure: Occurrence of new ulcerated calciphylaxis lesions
timeFrame: At 4 weeks and 12 weeks of rheopheresis treatment.
measure: Evolution of the self-reporting pain using Numeric Rating Scale (NRS)
timeFrame: from baseline (V0) to 12 weeks of rheopheresis (V2)
measure: Evolution of the level of antalgic consumed according to World Health Organisation (WHO) classification
timeFrame: from baseline (V0) to 12 weeks of rheopheresis (V2)
measure: Number of days without antibiotics
timeFrame: during the 12 weeks of rheopheresis treatment
measure: Quality of life by the Wound quality of life score (Wound-Qol)
timeFrame: form baseline (V0) and at 12 weeks
measure: Number of days discharged from hospital
timeFrame: during the 12 weeks of rheopheresis treatment
measure: Overall survival
timeFrame: at 12 weeks and 12 months after first rheopheresis.
measure: Change in inflammatory proteins
timeFrame: from baseline to 12 weeks-rheopheresis treatment
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Arnaud Lionet, MD
role: PRINCIPAL_INVESTIGATOR
References: