Phase III clinical trial of OPF-102 in renal failure patients

: Aiming at safer intravenous phosphorus repletion

Abstract

The conventional method of treating phosphorus deficiency by dipotassium phosphate injection as a phosphorus supplement may induce hyperkalemia. To address this challenge, Otsuka Pharmaceutical Factory, Inc. has developed an electrolyte solution (sodium phosphate injection [OPF-102]) that substitutes sodium phosphates for their potassium counterparts in the formulation. This solution can be used when there is a risk of high serum potassium concentrations. In this study, we evaluated the effectiveness and safety of OPF-102 for correction of serum phosphorus levels when administered to patients with renal failure who were undergoing hemodialysis and required phosphorus repletion. We administered OPF-102 intravenously to 10 subjects. In all subjects, the serum phosphorus concentrations normalized after administration of OPF-102. The patients' serum potassium concentrations, which fluctuated before administration of OPF-102, were not affected. In addition, there were no adverse events requiring clinical intervention during administration of OPF-102. OPF-102 is expected to be useful as a phosphorus supplement in clinical situations with a potential risk of inducing a high serum potassium concentrations.