Long-Term Assessment of the Safety and Efficacy of PA21 (Sucroferric Oxyhydroxide) in Japanese Hemodialysis Patients With Hyperphosphatemia: An Open-Label, Multicenter, Phase III Study

Abstract

The objective of this article was to assess the safety and efficacy of long-term administration of PA21. Phase III, open-label, long-term study in 15 sites in Japan. Japanese hemodialysis patients (N=161) with hyperphosphatemia aged ≥20years undergoing stable maintenance hemodialysis 3 times weekly, for ≥12weeks. After a 2-week observation period with their previous hyperphosphatemia therapy, patients began the 52-week treatment with PA21, which was administered orally at an initial dose of 250mg, 3 times daily, immediately before every meal (dosing range between 750 and 3,000mg/day). Safety was evaluated based on the development of adverse events and adverse drug reactions (ADRs). Efficacy was evaluated according to serum phosphorus concentration, corrected serum calcium concentration, and serum intact-parathyroid hormone concentration. The mean serum phosphorus concentration decreased from 5.46±1.06mg/dL at baseline to 5.00±1.17mg/dL at end of treatment. The serum phosphorus concentration was maintained within the target range (3.5-6.0mg/dL) throughout the 52weeks of the study period with a mean of 3.3 tablets per day of PA21. Most ADRs were mild, transient, and developed early during treatment, and the incidence was not shown to increase with long-term treatment. The most frequently reported ADR was diarrhea (22.4%). Treatment with PA21 was effective in lowering and maintaining target serum phosphorus concentrations in Japanese hemodialysis patients with hyperphosphatemia over 52weeks. PA21 was generally well tolerated in the long term.