NCT07522008 ICHARUS: Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms

Trial Parameters

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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