Expanded Home Hemodialysis trial (HHDx): Study Design and Baseline Characteristics of a Pragmatic Real-World Cohort

Background: Expanded hemodialysis (HDx), using medium cut-off (MCO) membranes, offers enhanced clearance of middle-molecule uremic toxins. While HDx has shown promising clinical results in center-based settings, its application in frequent home hemodialysis (HHD) remains understudied. This study aims to assess the safety, efficacy, and quality of life of patients treated with HDx at home (HHDx) in routine clinical practice. Methods: This is a pragmatic, multicenter, observational study (retrospective and prospective) including patients on HHDx in Spain. Adult patients (≥18 years) either incident or prevalent (<24 months on HHDx) are followed for up to 24 months. The primary outcome is safety, measured by serum albumin trends. Secondary outcomes include laboratory markers, dialysis efficacy (Kt/V, solute clearance), adverse events, nutritional status (bioimpedance), residual renal function, and quality of life (KDQOL-SF). Results: A total of 33 patients undergoing home hemodialysis (HHD) with medium cut-off dialyzers were enrolled. Baseline data collection includes demographics, comorbidities, dialysis prescription, laboratory values, clinical symptoms, and patient-reported outcomes. Statistical analysis will include intention-to-treat (ITT) and per-protocol sets (PPS), with generalized linear mixed models for repeated measures and Kaplan–Meier survival analysis for technique discontinuation. Conclusions: This real-world study will provide crucial data on the feasibility, tolerability, and potential benefits of HDx in a home setting, contributing evidence toward optimizing renal replacement strategies.