2026 Volume 59 Issue 3 Pages 96-106
In recent years, the aging of dialysis patients has advanced, necessitating increased caution regarding hypokalemia and hypomagnesemia. Furthermore, hypokalemia and hypomagnesemia in hemodialysis patients have been associated with a poor prognosis, leading to a reconsideration of potassium and magnesium concentrations in dialysates. AYD001 was developed while maintaining the characteristics of Carbostar Ⓡ dialysate (CAB), an acetate‒free dialysis solution. Compared with CAB, AYD001 increased potassium levels from 2.0 to 2.5 mEq/L and magnesium levels from 1.0 to 1.5 mEq/L, and reduced HCO3－ levels from 35 to 33 mEq/L. A crossover clinical trial comparing AYD001 and CAB was conducted involving 62 dialysis patients. The primary endpoint, the small molecule solute removal rate (urea nitrogen, creatine, and uric acid), was not significantly different between the two groups, demonstrating the similarity between AYD001 and CAB. The proportion of patients meeting the pre‒specified reference ranges for the secondary endpoints of post‒dialysis serum electrolytes (sodium, potassium, corrected calcium, and magnesium concentrations) and bicarbonate concentrations was compared between the groups. Serum potassium and magnesium concentrations remained significantly higher in the AYD001 than CAB group. Conversely, serum bicarbonate concentrations remained lower in the AYD001 than CAB group. No serious adverse events were observed in either group. AYD001 has comparable efficacy and safety to CAB and is considered to be a clinically relevant dialysate.
