ICHARUS: Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms

ConditionsChronic Kidney Disease 5D Uremia; Chronic

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAzienda Ospedaliera Brotzu

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population consists of adult patients with end-stage kidney disease (CKD stage 5D) receiving maintenance hemodialysis in participating dialysis centers. Eligible participants are individuals with a stable dialysis regimen who report at least one clinically relevant uremic symptom at baseline, as assessed by the Dialysis Symptom Index. Patients are enrolled during routine clinical care and followed prospectively after initiation of hemodialysis combined with hemoadsorption, in accordance with local standard practice.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants

are grouped into 1 trial group

Group A: HAHD Registry Cohort

Trial outcomes

Primary outcomes

Change in uremic symptom burden

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.

Time frame

Baseline and 3 months

Secondary outcomes

Absolute change in serum β2 microglobulin concentration

Absolute change in serum β2 microglobulin concentration (mg/L) from baseline to 1, 3, and 6 months.

Time frame

Baseline, 1, 3, and 6 months

Relative change in serum β2 microglobulin concentration

Percent change in serum β2 microglobulin concentration from baseline to 1, 3, and 6 months.

Time frame

Baseline, 1, 3, 6 months

Change in erythropoietin resistance index

Change in the erythropoietin resistance index (ERI), calculated by dividing the weekly weight-adjusted dose (IU/kg/week) of the drug by the patient's hemoglobin level (g/dL), from baseline to 3 and 6 months. This measure is used to assess how well a patient responds to Erythropoiesis-Stimulating Agents.

Time frame

Baseline, 3 and 6 months

Incidence of treatment emergent adverse events

The study will evaluate treatment-emergent adverse events recording the total number of events from baseline to 6 months in relation to the total number of participants (%) and classify them according to the Common Terminology Criteria for Adverse Events (CTCAE).

Time frame

Baseline, 6 months

Other outcomes

Absolute change in serum parathyroid hormone concentration

The study will evaluate the absolute change in serum parathyroid hormone concentration (pg/mL), from baseline to 1, 3, and 6 months.

Time frame

Baseline, 1, 3, and 6 months

Relative change in serum parathyroid hormone concentration

Relative change in serum parathyroid hormone concentration will be assessed as the percent change from baseline compared to 1, 3, and 6 months.

Time frame

Baseline, 1, 3, and 6 months

Absolute change in serum indoxyl sulfate concentration

Absolute change in total serum indoxyl sulfate concentration will be assessed as the difference in indoxyl sulfate levels (µmol/L) from baseline to 1, 3, and 6 months.

Time frame

Baseline, 1, 3, and 6 months.

Relative change in serum indoxyl sulfate concentration

The study will evaluate the relative change in total indoxyl sulfate concentration, measured as a percent change (%) from baseline to 1, 3, and 6 months.

Time frame

Baseline, 1, 3, and 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliera Brotzu

Lead sponsor

International Renal Research Institute Vicenza

Collaborator

Source ClinicalTrials.gov

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