ICHARUS: Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms

NCT07522008 | Recruiting

• 1 other identifier: ICHARUS-01/2025
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease 5D; Uremia; Chronic

Keywords

Hemoadsorption; Hemodialysis; HAHD; Protein-bound uremic toxins; Middle molecules; Uremic symptoms; Patient-reported outcomes; Quality of life; Real-world registry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Absolute change in serum β2 microglobulin concentration

  Baseline, 1, 3, and 6 months

• Relative change in serum β2 microglobulin concentration

  Baseline, 1, 3, 6 months

• Change in erythropoietin resistance index

  Baseline, 3 and 6 months

• Incidence of treatment emergent adverse events

  Baseline, 6 months

• Change in 5 D Itch Scale score

  Baseline, 6 months

Other Outcomes (21)

• Absolute change in serum parathyroid hormone concentration

  Baseline, 1, 3, and 6 months

• Relative change in serum parathyroid hormone concentration

  Baseline, 1, 3, and 6 months

• Absolute change in serum indoxyl sulfate concentration

  Baseline, 1, 3, and 6 months.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Renal Research Institute Vicenza: collaborator
• Azienda Ospedaliera Brotzu: lead

Study Sites (1)

S.C.D.U. Nefrologia, Dialisi e Trapianto ARNAS G.Brotzu, Cagliari

Cagliari, Italy, 09100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples collected as part of routine clinical care for standard laboratory assessments (e.g., inflammatory markers, uremic solutes, and other biochemical parameters). Samples are not collected specifically for genetic analyses, and no DNA extraction or genetic testing is planned. Any retained samples are used exclusively for biochemical analyses related to the study objectives, in accordance with local regulations and ethical approvals.

MeSH Terms

Conditions

Uremia; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Claudio Ronco, MD

  International Renal Research Institute of Vicenza

  STUDY DIRECTOR

Central Study Contacts

Matteo Floris, MD

CONTACT

*393207718720; matteo.floris@aob.it

Matteo Marcello, MD

CONTACT

matteo.marcello@aulss8.veneto.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Nephrology, Dialysis and Transplantation Unit G. Brotzu Hospital of Cagliari - Assistant Professor (tenure-track) University of Cagliari

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: April 13, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

IT (1)