Low-Sodium Peritoneal Dialysis Solution (Na 126 mmol/L) for Enhanced Sodium Removal: A Multicenter Randomized Controlled Trial

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Rationale & Objective Fluid overload is a major cause of treatment failure in patients undergoing peritoneal dialysis (PD), and insufficient sodium removal is involved with this condition. This study evaluated the efficacy and safety of a novel low-sodium PD solution (Na 126 mmol/L, glucose 1.6%) combined with standard-sodium PD solutions as a new approach to enhance sodium removal. Study Design & Participants In this multicenter, double-blind, randomized, parallel-group study, outpatient PD patients at 20 facilities in Japan were randomly assigned (2:1) to the low-sodium PD solution group or the standard sodium PD solution group (Na 135 mmol/L, glucose 1.35%). Exposure The test solution replaced one daily exchange and was combined with at least one standard PD solution. Patients who met dose-escalation criteria at week 4 switched to twice-daily dosing. Outcomes The primary outcome was the change in daily peritoneal sodium removal from baseline to week 8. Secondary outcomes included peritoneal sodium removal per bag exchange, total daily (peritoneal and urinary) sodium, and water removal, and dialysis adequacy. Analytical Approach Efficacy, including sodium removal in PD treatment, was analyzed in the full analysis set; safety was assessed in all patients. Results The mean change in daily peritoneal sodium removal was significantly higher in the low-sodium PD solution group (n = 51, 28.7 ± 36.2 mmol/day) than in the standard-sodium PD solution group (n = 27, −6.3 ± 26.2 mmol/day; P < 0.001). Other outcomes showed no significant differences. Drug-related adverse events (mainly hyponatremia) were observed in the low-sodium PD solution group; however, they were generally mild and completely reversible. Limitations Participants with relatively preserved residual renal function and incremental peritoneal dialysis were overrepresented. Conclusions The low-sodium PD solution, when combined with standard PD solutions, increased sodium removal without compromising dialysis adequacy or residual renal function. Plain-Language Summary Fluid overload is common in patients undergoing peritoneal dialysis, a home-based therapy for kidney failure. It is closely linked to excess sodium and can lead to hypertension, cardiovascular complications, and discontinuation of dialysis. Although sodium restriction is the standard approach, changing dietary habits is difficult for many patients. To address this issue, we developed a low-sodium dialysis solution to enhance sodium removal. Patients used this solution once or twice daily in place of standard fluids. The results showed increased sodium removal without adverse effects. This simple modification may improve fluid control and support better long-term management in peritoneal dialysis patients.