Italian cooperative hemoadsorption for relieving uremic symptoms
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.
This registry will follow adults on maintenance hemodialysis to see if adding hemoadsorption to their dialysis helps relieve persistent uremic symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Brotzu Academic / other |
| Locations | 1 site (Cagliari, Italy) |
| Trial ID | NCT07522008 on ClinicalTrials.gov |
What this trial studies
ICHARUS is a prospective, multicenter, observational registry collecting real-world data on hemodialysis combined with hemoadsorption (HAHD) in adults with end-stage kidney disease on maintenance dialysis. Patients are enrolled when their treating physician prescribes hemoadsorption as part of routine care for persistent moderate-to-severe uremic symptoms. The registry records indications, treatment patterns, changes in symptom scores and patient-reported outcomes, and safety events without altering standard clinical practice. Data will describe how HAHD is used across centers and how symptoms and adverse events evolve over time.
Who should consider this trial
Good fit: Adults (≥18 years) with CKD stage 5D on stable maintenance hemodialysis for at least 3 months who have at least one moderate-to-severe uremic symptom and are planned for hemoadsorption per routine clinical care are ideal candidates.
Not a fit: Patients with recent acute illness or infection, planned transplantation during follow-up, very limited life expectancy, inability to complete questionnaires, or symptoms not related to protein-bound or middle-molecule toxins may be unlikely to benefit from HAHD in this registry.
Why it matters
Potential benefit: If successful, HAHD could reduce stubborn uremic symptoms and improve quality of life for patients on maintenance hemodialysis.
How similar studies have performed: Small observational and mechanistic studies suggest hemoadsorption can enhance removal of protein-bound and middle-molecule toxins and may improve symptoms, but large randomized trials providing definitive evidence are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cagliari, Italy
- S.C.D.U. Nefrologia, Dialisi e Trapianto ARNAS G.Brotzu, Cagliari — Cagliari, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Matteo Floris, MD
- Email: matteo.floris@aob.it
- Phone: *393207718720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.