ICHARUS: Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms (ICHARUS)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease 5D; Uremia; Chronic

Detailed Description

Rationale Despite major advances in dialysis technology, a substantial proportion of patients receiving maintenance hemodialysis continue to experience persistent uremic symptoms, including pruritus, fatigue, sleep disturbances, reduced physical performance, and impaired quality of life. Conventional dialysis modalities primarily rely on diffusive and convective solute transport and may be insufficient to remove specific classes of uremic toxins, particularly protein-bound solutes and selected middle molecules. Hemoadsorption combined with hemodialysis (HAHD) provides an additional adsorptive mechanism that may enhance the removal of these solutes and potentially contribute to symptom relief.

Study overview The ICHARUS study (Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms) is a prospective, multicenter, observational real-world registry designed to describe the clinical use of HAHD in adult patients undergoing maintenance hemodialysis. The registry aims to collect standardized data on indications, treatment patterns, symptom evolution, and safety outcomes associated with HAHD when prescribed as part of routine clinical practice.

Study design ICHARUS is a non-interventional cohort registry. Patient enrollment is based on clinical indication for hemoadsorption, as determined by the treating physician, in the presence of persistent uremic symptoms despite optimized conventional dialysis. The decision to initiate, continue, or discontinue hemoadsorption is entirely independent of study participation and follows local clinical practice. No randomization, mandated treatment changes, or protocol-driven interventions are applied.

Treatment characteristics Hemoadsorption is performed in combination with standard hemodialysis modalities, including low-flux hemodialysis, high-flux hemodialysis, expanded hemodialysis, or hemodiafiltration, according to center expertise and patient-specific prescription. Dialysis session duration, blood and dialysate flow rates, anticoagulation strategy, and treatment frequency are not dictated by the registry and remain at the discretion of the treating team.

Data collection and follow-up Data are collected at baseline and during routine follow-up visits at approximately 1, 3, and 6 months after enrollment. Collected variables include demographic and clinical characteristics, dialysis prescription parameters, patient-reported symptoms, selected laboratory markers, and safety-related information. Follow-up assessments are aligned with standard clinical care and do not require additional procedures beyond routine practice.

Safety considerations As an observational registry, ICHARUS does not introduce experimental treatments or additional risks beyond standard clinical care. Adverse events and safety signals potentially associated with HAHD are recorded descriptively, without predefined stopping rules or intervention thresholds.

Ethical aspects The registry is conducted in accordance with the Declaration of Helsinki and applicable local regulations. Ethical approval is obtained at each participating center prior to patient enrollment. Written informed consent is collected according to local requirements.

Objectives and perspective The primary objective of the ICHARUS registry is to describe real-world patterns of HAHD use and associated changes in uremic symptoms and patient-reported outcomes over time. Secondary objectives include characterization of laboratory trends and treatment tolerability. By providing structured real-world evidence across multiple centers, the registry aims to support harmonization of clinical practice, improve patient endophenotyping, and generate hypotheses for future interventional studies.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Matteo Floris, MD; Phone Number: *393207718720; Email: matteo.floris@aob.it
• Study Contact Backup: Name: Matteo Marcello, MD; Email: matteo.marcello@aulss8.veneto.it

Study Locations

• Italy
  • Italy
    • Cagliari, Italy, Italy, 09100
      • Recruiting
      • S.C.D.U. Nefrologia, Dialisi e Trapianto ARNAS G.Brotzu, Cagliari
      • Contact: Matteo Floris, MD; Email: matteo.floris@aob.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

HAHD Registry Cohort; Adult patients with end-stage kidney disease undergoing maintenance hemodialysis and enrolled in the ICHARUS prospective observational registry. Patients are included based on the presence of persistent uremic symptoms and a clinical decision to use hemodialysis combined with hemoadsorption as part of routine care. All participants are followed longitudinally according to standard clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in serum β2 microglobulin concentration	Absolute change in serum β2 microglobulin concentration (mg/L) from baseline to 1, 3, and 6 months.	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.	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.	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).	Baseline, 6 months
Change in 5 D Itch Scale score	Change in pruritus score measured by 5 D Itch Scale (points) from baseline to 6 months.	Baseline, 6 months
Change in International Restless Legs Syndrome Rating Scale score	Change in restless legs syndrome severity by measuring the total International Restless Legs Syndrome Rating Scale score (points), from baseline to 6 months.	Baseline, 6 months
Change in Pittsburgh Sleep Quality Index score	The study will evaluate the change in sleep quality by measuring the Pittsburgh Sleep Quality Index global score (points), from baseline to 6 months.	Baseline, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, 1, 3, and 6 months
Absolute change in serum p cresyl sulfate (total fraction)	Absolute change in total serum p-cresyl sulfate concentration will be assessed as the difference in p-cresyl sulfate levels (µmol/L) from baseline to 1, 3, and 6 months.	Baseline, 1, 3, and 6 months
Relative change in serum p cresyl sulfate (total fraction)	The study will evaluate the relative change in total p-cresyl sulfate concentration, measured as a percent change (%) from baseline to 1, 3, and 6 months.	Baseline to 1, 3, and 6 months
Absolute change in serum p cresyl sulfate (free fraction)	Absolute change in free serum p-cresyl sulfate concentration will be assessed as the difference in free p-cresyl sulfate levels (µmol/L) from baseline to 1, 3, and 6 months.	Baseline, 1, 3, and 6 months
Relative change in serum p cresyl sulfate (free fraction)	The study will evaluate the relative change in free p-cresyl sulfate concentration, measured as a percent change (%) from baseline to 1, 3, and 6 months.	Baseline to 1, 3, and 6 months
Absolute change in serum ICAM 1 concentration	Absolute change in serum ICAM-1 concentration will be assessed as the difference in serum ICAM-1 levels (ng/mL) from baseline to 1, 3, and 6 months.	Baseline, 1, 3, and 6 months
Absolute change in serum VCAM 1 concentration	Absolute change in serum VCAM-1 concentration will be assessed as the difference in serum VCAM-1 levels (ng/mL) from baseline to 1, 3, and 6 months.	Baseline, 1, 3, and 6 months
Change in Malnutrition Inflammation Score	Nutritional status will be evaluated using the Malnutrition Inflammation Score (points), and change will be assessed by the difference from baseline to 3 and 6 months.	Baseline, 3, 6 months
Change in protein-energy wasting score	Protein-energy wasting will be assessed according to score derived from the International Society of Renal Nutrition and Metabolism criteria (points), and change will be defined as the difference from baseline to 1, 3 and 6 months.	Baseline, 1, 3 and 6 months
Hospitalization rate	Hospitalization rate will be assessed as the number of all-cause hospitalizations per patient during the 6-month follow-up period.	6 months
Incidence of non-fatal cardiovascular events	Incidence of non-fatal cardiovascular events will be assessed as the number of non-fatal cardiovascular events recorded during the 6-month follow-up period.	6 months
Change in health and well-being status by KDQOL-36 score	Change in health and well-being status measured by KDQOL-36 score (points) will be assessed as the difference in total score from baseline to 3 and 6 months.	Baseline, 3 and 6 months
Change in Dialysis Symptom Index (DSI) total score at 6 months	Change in Dialysis Symptom Index (points) total score will be assessed as the difference from baseline to 6 months.	Baseline, 6 months
Change in Dialysis Symptom Index item-specific scores	Change in patient-reported symptom burden will be assessed as the difference from baseline in item-specific scores (points) on the Dialysis Symptom Index at 3 months after initiation of HA-HD.	Baseline, 3 months
Change in proteomic profile measured by Olink® Q100 platform	Change in proteomic profile will be assessed as the difference in protein expression levels, measured in NPX (Normalized Protein eXpression) using the Olink® Q100 platform, between baseline and 1, 3 and 6 months after initiation of HA-HD.	Baseline, 1, 3, 6 months
Change in doses of supportive dialysis-related medication	Change in dialysis-related medication will be assessed as the difference of the number of doses from baseline to 3 months in the composite of iron therapy, nutritional supplements, phosphate binders, and active vitamin D or etelcalcetide use.	Baseline, 3 months.
Change in number of antihypertensive medications	Change in antihypertensive medication use will be assessed as the difference from baseline in the number of antihypertensive medications prescribed at 1, 3, and 6 months.	Baseline, 1, 3 and 6 months
Change in nursing workload score	Change in the nursing workload dedicated to patient care measured by the Nursing Activities Score (points) from baseline to 1, 3 and 6 months	Baseline, 1, 3, 6 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Brotzu
• Collaborators: International Renal Research Institute Vicenza
• Investigators: Study Director: Claudio Ronco, MD, International Renal Research Institute of Vicenza

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 14, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Hemodialysis; Patient-reported outcomes; Hemoadsorption; Middle molecules; Protein-bound uremic toxins; HAHD; Uremic symptoms; Real-world registry
• Additional Relevant MeSH Terms: Urogenital Diseases; Organizing Pneumonia; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease; Bronchiolitis Obliterans Syndrome; Uremia
• Other Study ID Numbers: ICHARUS-01/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified data, upon reasonable request, after publication
• IPD Sharing Time Frame: De-identified individual participant data and supporting documents will be made available beginning 6 months after publication of the primary study results and will remain available for up to 5 years thereafter.
• IPD Sharing Access Criteria: Access to de-identified individual participant data and supporting documents will be granted to qualified researchers who submit a methodologically sound research proposal. Proposals will be reviewed by the study steering committee. Data access will require approval of the proposal and the execution of a data-sharing agreement. Data will be shared to achieve the aims of the approved proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No