Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Italy / NCT07522008
Recruiting Observational

ICHARUS: Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms

NCT07522008 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda Ospedaliera Brotzu
Phase
Observational
Started
2026-03-15
Last updated
2026-04-21

Condition(s) studied

Chronic Kidney Disease 5DUremia; Chronic

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in uremic symptom burden — 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.

Trial sites (1)

FacilityCityRegionStatus
S.C.D.U. Nefrologia, Dialisi e Trapianto ARNAS G.Brotzu, Cagliari Cagliari Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07522008 on ClinicalTrials.gov ↗ ← All trials in Italy