ICHARUS: Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms. A Prospective Observational Cohort Study to Assess the Effectiveness and Safety of Hemoadsorption in Chronic Hemodialysis Patients With Refractory Uremic Symptoms: An Italian Real-World Registry.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in uremic symptom burden
研究概览
简要总结
Background:
Many patients receiving maintenance hemodialysis continue to experience persistent uremic symptoms, such as pruritus, fatigue, sleep disorders, reduced physical performance, and impaired quality of life, despite optimized dialysis prescriptions. Conventional dialysis techniques mainly rely on diffusion and convection and may be insufficient to remove certain uremic toxins, particularly protein-bound and middle-molecule solutes.
Purpose:
The ICHARUS study (Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms) is a prospective, observational, real-world registry designed to evaluate the clinical use of hemodialysis combined with hemoadsorption (HAHD) in patients with persistent uremic symptoms.
Study design:
ICHARUS is a multicenter registry enrolling adult patients on maintenance hemodialysis in whom hemoadsorption is prescribed according to routine clinical practice. Hemoadsorption is added to standard dialysis sessions without modifying the underlying dialysis modality or prescription. The study does not involve randomization or experimental interventions.
Outcomes:
The registry will collect data on patient-reported symptoms, quality of life, selected laboratory parameters, and safety outcomes at baseline and during follow-up at 1, 3, and 6 months. The aim is to describe symptom evolution, tolerability, and real-world treatment patterns associated with HAHD.
Significance:
By collecting standardized real-world data across multiple centers, the ICHARUS registry aims to improve understanding of the potential role of hemoadsorption in chronic hemodialysis, support harmonization of clinical practice, and generate hypotheses for future interventional studies.
详细描述
Rationale Despite major advances in dialysis technology, a substantial proportion of patients receiving maintenance hemodialysis continue to experience persistent uremic symptoms, including pruritus, fatigue, sleep disturbances, reduced physical performance, and impaired quality of life. Conventional dialysis modalities primarily rely on diffusive and convective solute transport and may be insufficient to remove specific classes of uremic toxins, particularly protein-bound solutes and selected middle molecules. Hemoadsorption combined with hemodialysis (HAHD) provides an additional adsorptive mechanism that may enhance the removal of these solutes and potentially contribute to symptom relief.
Study overview The ICHARUS study (Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms) is a prospective, multicenter, observational real-world registry designed to describe the clinical use of HAHD in adult patients undergoing maintenance hemodialysis. The registry aims to collect standardized data on indications, treatment patterns, symptom evolution, and safety outcomes associated with HAHD when prescribed as part of routine clinical practice.
Study design ICHARUS is a non-interventional cohort registry. Patient enrollment is based on clinical indication for hemoadsorption, as determined by the treating physician, in the presence of persistent uremic symptoms despite optimized conventional dialysis. The decision to initiate, continue, or discontinue hemoadsorption is entirely independent of study participation and follows local clinical practice. No randomization, mandated treatment changes, or protocol-driven interventions are applied.
Treatment characteristics Hemoadsorption is performed in combination with standard hemodialysis modalities, including low-flux hemodialysis, high-flux hemodialysis, expanded hemodialysis, or hemodiafiltration, according to center expertise and patient-specific prescription. Dialysis session duration, blood and dialysate flow rates, anticoagulation strategy, and treatment frequency are not dictated by the registry and remain at the discretion of the treating team.
Data collection and follow-up Data are collected at baseline and during routine follow-up visits at approximately 1, 3, and 6 months after enrollment. Collected variables include demographic and clinical characteristics, dialysis prescription parameters, patient-reported symptoms, selected laboratory markers, and safety-related information. Follow-up assessments are aligned with standard clinical care and do not require additional procedures beyond routine practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (≥18 years) with end-stage kidney disease (CKD stage 5D) on maintenance hemodialysis.
- •Stable hemodialysis treatment for at least 3 months prior to enrollment.
- •Presence of at least one moderate-to-severe uremic symptom, as identified by the Dialysis Symptom Index at screening.
- •Planned treatment with hemodialysis combined with hemoadsorption according to local clinical practice.
- •Ability to provide written informed consent.
排除标准
- •Acute illness, active infection, or hospitalization within 4 weeks prior to enrollment.
- •Planned kidney transplantation within the study follow-up period.
- •Life expectancy less than 6 months due to non-renal comorbid conditions.
- •Inability to complete patient-reported outcome questionnaires.
- •Participation in another interventional clinical study that could interfere with study outcomes.
研究组 & 干预措施
HAHD Registry Cohort
Adult patients with end-stage kidney disease undergoing maintenance hemodialysis and enrolled in the ICHARUS prospective observational registry. Patients are included based on the presence of persistent uremic symptoms and a clinical decision to use hemodialysis combined with hemoadsorption as part of routine care. All participants are followed longitudinally according to standard clinical practice.
结局指标
主要结局
Change in uremic symptom burden
时间窗: Baseline and 3 months
Change in total patient-reported uremic symptom burden, measured by the questionnaire Dialysis Symptom Index (points), from baseline to month 3 after initiation of hemadsorption-assisted haemodialysis.
次要结局
- Absolute change in serum β2 microglobulin concentration(Baseline, 1, 3, and 6 months)
- Relative change in serum β2 microglobulin concentration(Baseline, 1, 3, 6 months)
- Change in erythropoietin resistance index(Baseline, 3 and 6 months)
- Incidence of treatment emergent adverse events(Baseline, 6 months)
- Change in 5 D Itch Scale score(Baseline, 6 months)
- Change in International Restless Legs Syndrome Rating Scale score(Baseline, 6 months)
- Change in Pittsburgh Sleep Quality Index score(Baseline, 6 months)
研究者
Matteo Floris
M.D. Nephrology, Dialysis and Transplantation Unit G. Brotzu Hospital of Cagliari - Assistant Professor (tenure-track) University of Cagliari
Azienda Ospedaliera Brotzu