Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 29
- 主要终点
- Percentage of patients with complete wound healing of the calciphylaxis-mediated ischemic lesions after 12 weeks of rheopheresis treatment (a total of 17 sessions).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Rheopheresis procedure (Procedure)
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.
干预措施: Sham-apheresis (Procedure)
结局指标
主要结局
Percentage of patients with complete wound healing of the calciphylaxis-mediated ischemic lesions after 12 weeks of rheopheresis treatment (a total of 17 sessions).
时间窗: at 12 weeks of treatement
Complete wound healing is defined as the absence of livedoid peri-lesional inflammation with presence of granulation tissue (stage 3 healing process) and/or epithelization (stage 4) over the entire ulcer surface of calciphylactic lesions. The healing of the lesions will be illustrated with a photographic support. And the pictures will be examined a second time in a centralized and blind way by two referring dermatologists. In case of multiple calciphylaxis skin lesions, monitoring and evaluation will be done on the largest lesion at the time of patient's inclusion.
次要结局
- Percentage of patient with partial wound healing of the calciphylaxis mediated lesions after rheopheresis treatment.(At 4 weeks and 12 weeks of rheopheresis treatment.)
- Occurrence of new ulcerated calciphylaxis lesions(At 4 weeks and 12 weeks of rheopheresis treatment.)
- Evolution of the self-reporting pain using Numeric Rating Scale (NRS)(from baseline (V0) to 12 weeks of rheopheresis (V2))
- Evolution of the level of antalgic consumed according to World Health Organisation (WHO) classification(from baseline (V0) to 12 weeks of rheopheresis (V2))
- Number of days without antibiotics(during the 12 weeks of rheopheresis treatment)
- Quality of life by the Wound quality of life score (Wound-Qol)(form baseline (V0) and at 12 weeks)
- Number of days discharged from hospital(during the 12 weeks of rheopheresis treatment)
- Overall survival(at 12 weeks and 12 months after first rheopheresis.)
- Change in inflammatory proteins(from baseline to 12 weeks-rheopheresis treatment)