Rheopheresis as Adjuvant Treatment of Calciphylaxis

Официальное название

Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• Percentage of patients with complete wound healing of the calciphylaxis-mediated ischemic lesions after 12 weeks of rheopheresis treatment (a total of 17 sessions). [Срок оценки: at 12 weeks of treatement]

Вторичные конечные точки (9)

• Percentage of patient with partial wound healing of the calciphylaxis mediated lesions after rheopheresis treatment. [Срок оценки: At 4 weeks and 12 weeks of rheopheresis treatment.]
• Occurrence of new ulcerated calciphylaxis lesions [Срок оценки: At 4 weeks and 12 weeks of rheopheresis treatment.]
• Evolution of the self-reporting pain using Numeric Rating Scale (NRS) [Срок оценки: from baseline (V0) to 12 weeks of rheopheresis (V2)]
• Evolution of the level of antalgic consumed according to World Health Organisation (WHO) classification [Срок оценки: from baseline (V0) to 12 weeks of rheopheresis (V2)]
• Number of days without antibiotics [Срок оценки: during the 12 weeks of rheopheresis treatment]
• Quality of life by the Wound quality of life score (Wound-Qol) [Срок оценки: form baseline (V0) and at 12 weeks]
• Number of days discharged from hospital [Срок оценки: during the 12 weeks of rheopheresis treatment]
• Overall survival [Срок оценки: at 12 weeks and 12 months after first rheopheresis.]
• Change in inflammatory proteins [Срок оценки: from baseline to 12 weeks-rheopheresis treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Диагностика

Центры проведения

Франция · 29 центров

• 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
• … и ещё 21 центр

Идентификаторы

NCT: NCT04654000 · 2020_05 · 2020-A02896-33

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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