Rheopheresis as Adjuvant Treatment of Calciphylaxis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rheopheresis procedure, Sham-apheresis.
- Who it may be relevant to
- Registry conditions: Metabolic Disorder, End Stage Renal Disease, Rare Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial
Overview
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.
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. 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.
Interventions
- 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 - 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.
Primary outcome measures
- 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]
Secondary outcome measures (9)
- 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.]
- Occurrence of new ulcerated calciphylaxis lesions [Time frame: At 4 weeks and 12 weeks of rheopheresis treatment.]
- Evolution of the self-reporting pain using Numeric Rating Scale (NRS) [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 [Time frame: from baseline (V0) to 12 weeks of rheopheresis (V2)]
- Number of days without antibiotics [Time frame: during the 12 weeks of rheopheresis treatment]
- Quality of life by the Wound quality of life score (Wound-Qol) [Time frame: form baseline (V0) and at 12 weeks]
- Number of days discharged from hospital [Time frame: during the 12 weeks of rheopheresis treatment]
- Overall survival [Time frame: at 12 weeks and 12 months after first rheopheresis.]
- Change in inflammatory proteins [Time frame: from baseline to 12 weeks-rheopheresis treatment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
France · 29 centers
- CHU d'Angers — Angers
- CHU d'Arras — Arras
- CHU d'Auxerre — Auxerre
- CHU de Besançon, Hôpital Jean Minjoz — Besançon
- CH de Béthune — Béthune
- CH de Boulogne sur Mer — Boulogne-sur-Mer
- CHU de Bordeaux — Bourdeaux
- CHRU de Brest — Brest
- … and 21 more centers
Identifiers
NCT: NCT04654000 · 2020_05 · 2020-A02896-33