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Kidney Week

Abstract: TH-PO0885

ICHARUS: Italian Cooperative Hemoadsorption Study for Relief of Uremic Symptoms

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Floris, Matteo, Universita degli Studi di Cagliari, Cagliari, Sardinia, Italy
  • Marcello, Matteo, Ospedale San Bortolo di Vicenza, Vicenza, Veneto, Italy
  • Gembillo, Guido, Universita degli Studi di Messina, Messina, Sicily, Italy
  • Zappulo, Fulvia, Universita degli Studi di Bologna, Bologna, Emilia-Romagna, Italy
  • Fiorentino, Marco, Universita degli Studi di Bari Aldo Moro, Bari, Apulia, Italy
  • Samoni, Sara, IRCCS Ca' Granda Ospedale Policlinico Milan, Milan, Lombardia, Italy
  • Cerqueira, Tiago Lemos, Dresden International University GmbH, Dresden, SN, Germany
  • Murgia, Michela, Universita degli Studi di Cagliari, Cagliari, Sardinia, Italy
  • Santoro, Domenico, Universita degli Studi di Messina, Messina, Sicily, Italy
  • La Manna, Gaetano, Universita degli Studi di Bologna, Bologna, Emilia-Romagna, Italy
  • Castellano, Giuseppe, Universita degli Studi di Milano, Milan, Lombardy, Italy
  • Gesualdo, Loreto, Universita degli Studi di Bari Aldo Moro, Bari, Apulia, Italy
  • Pani, Antonello, Universita degli Studi di Cagliari, Cagliari, Sardinia, Italy
  • Ronco, Claudio, International Renal Research Institute of Vicenza (IRRIV), Vicenza, Veneto, Italy
Background

Persistent uremic syndrome in patients undergoing maintenance hemodialysis reflects the limited ability of conventional diffusive and convective clearance to remove protein-bound uremic toxins (PBUTs) and larger solutes. The retention of biologically active molecules contributes to chronic inflammation, endothelial dysfunction, and a high symptom burden, significantly impairing health-related quality of life.

Methods

ICHARUS is a national prospective observational registry generating evidence on symptom-driven extracorporeal hemoadsorption integration into the hemodialysis circuit (HA-HD). The primary endpoint is change in total symptom burden, assessed by the Dialysis Symptom Index (DSI), baseline to 3 months. Sample size was calculated to detect a medium effect (Cohen's d = 0.5) on DSI with 95% power and a 15% dropout rate. It will enroll 120 adults with refractory uremic symptoms despite optimized standard dialysis. Secondary analyses include PROMs: 5-D Itch Scale, International Restless Legs Syndrome Rating Scale, Pittsburgh Sleep Quality Index, and KDQOL-36. Biomarkers include β2-microglobulin kinetics, erythropoietin resistance index (ERI), and PBUTs. Treatment-emergent adverse events (TEAEs) will be monitored throughout follow-up.

Results

The protocol includes at least one weekly HA-HD session with 6-month follow-up. The study will estimate the Minimal Clinically Important Difference for DSI using anchor-based methods, defining meaningful improvement for patients starting HA-HD. Based on baseline DSI scores, improvements are expected in targeted PROMs and quality of life. Biomarker clearance may improve and reduce ERI. The study will provide a safety overview by collecting TEAEs and hospitalization rates in a real-world setting. Sample collection may identify proteomic biomarkers associated with treatment response, helping identify patients most likely to benefit from HA-HD.

Conclusion

ICHARUS is the first prospective multicenter registry of symptom-driven HA-HD in chronic dialysis. By integrating biochemical and patient-reported outcomes, it aims to identify distinct response endophenotypes, support personalization, and inform future interventional trials.