Actively Recruiting
ICHARUS: Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms Observational Registry Evaluating Hemoadsorption in Chronic Hemodialysis Patients
Led by Azienda Ospedaliera Brotzu · Updated on 2026-04-21
120
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliera Brotzu
Lead Sponsor
I
International Renal Research Institute Vicenza
Collaborating Sponsor
AI-Summary
What this Trial Is About
Many adults with end-stage kidney disease receiving maintenance hemodialysis still suffer from ongoing uremic symptoms such as itching, fatigue, sleep problems, reduced physical ability, and a lower quality of life, despite optimized dialysis treatments. These symptoms may persist because conventional dialysis methods may not fully remove certain toxins, particularly protein-bound and middle-molecule solutes. The ICHARUS study is a prospective, observational registry designed to evaluate the use of hemodialysis combined with hemoadsorption (HAHD) in adults with these persistent symptoms. The study enrolls adult patients already receiving maintenance hemodialysis who are prescribed hemoadsorption as part of routine care to help manage uremic symptoms. Hemoadsorption is added to standard dialysis sessions without changing the dialysis type or prescription. The registry collects data without altering treatment, following patients over time as they receive their usual care combined with hemoadsorption. Participants are followed at baseline and during routine visits approximately 1, 3, and 6 months after enrollment. The study collects data on patient symptoms, quality of life, selected lab markers such as serum b22 microglobulin, and safety outcomes related to hemoadsorption. This real-world data aims to describe symptom changes, treatment patterns, tolerability, and safety, helping to improve understanding and guide future research on hemoadsorption in chronic hemodialysis patients.
CONDITIONS
Brief Title
ICHARUS: Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years or older) with end-stage kidney disease (CKD stage 5D) on maintenance hemodialysis
- Stable hemodialysis treatment for at least 3 months before enrollment
- Presence of at least one moderate-to-severe uremic symptom measured by the Dialysis Symptom Index
- Planned treatment with hemodialysis combined with hemoadsorption according to local practice
- Ability to provide written informed consent
You will not qualify if you...
- Acute illness, active infection, or hospitalization within 4 weeks before enrollment
- Planned kidney transplantation during the study follow-up period
- Life expectancy less than 6 months due to non-renal conditions
- Inability to complete patient-reported outcome questionnaires
- Participation in another interventional clinical study that could affect study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants who undergo routine hemodialysis combined with hemoadsorption as part of their standard care are observed to collect data on symptoms, laboratory markers, and safety outcomes.
Baseline visit and follow-up visits at approximately 1, 3, and 6 months
Trial Site Locations
Total: 1 location
1
S.C.D.U. Nefrologia, Dialisi e Trapianto ARNAS G.Brotzu, Cagliari
Cagliari, Italy, Italy, 09100
Actively Recruiting
Research Team
M
Matteo Floris, MD
M
Matteo Marcello, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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