An observational study in Chronic Kidney Disease 5D and Uremia; Chronic, sponsored by Azienda Ospedaliera Brotzu. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Azienda Ospedaliera Brotzu · Observational
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.
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.
53 studies on the registry are indexed under Uremia; 10 are open to participants now.
This study's planned enrollment of 120 is above the median of 105 across 12 observational studies indexed under Uremia.
Browse Uremia studies →Azienda Ospedaliera Brotzu is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
Change in 5 D Itch Scale score
Change in pruritus score measured by 5 D Itch Scale (points) from baseline to 6 months.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, 1, 3, 6 months
Plan to share: Yes — de-identified data, upon reasonable request, after publication
Supporting information: 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.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Feb 2027, 11 months after the start.
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