Therapeutic Research

Abstract

Object：Hyperphosphatemia negatively impact on the prognosis in patients with chronic kidney disease（CKD）. In this post‒marketing surveillance, the safety and efficacy of ferric citrate hydrate, an iron‒based phosphate binder, was examined in hyperphosphatemia patients with CKD. Methods：In a prospective observational study for 2‒years, the safety（incidence of adverse drug reactions, the serum levels of ferritin, transferrin saturation［TSAT］and hemoglobin）and the efficacy （serum phosphate, corrected calcium, and intact parathyroid hormone［iPTH］） endpoints were assessed. Results：Of 2811 patients enrolled, 2253（dialysis：1565；non‒dialysis：688）and 2011（dialysis：1412；non‒dialysis：599）were subjected to the safety and efficacy analyses, respectively. A total of 387 patients（17.2％）developed drug‒related adverse reactions, including diarrhoea （3.8％）, serum ferritin increased（2.9％）, constipation （1.7％）and heamoglobin elevation（1.2％）. The median value of ferritin was changed, 48.0［22.8, 97.0］ng/mL and 80.8［44.4, 148.0］ng/mL at baseline, and 147.0［85.9, 245.7］ ng/mL and 176.0 ［74.2, 343.0］ng/mL at 104th week in dialysis group and non‒dialysis group, respectively. The change in heamoglobin and TSAT were moderate in each group. The efficacy analysis demonstrated a decrease in serum phosphate level at 4th week, but negligible changes in serum calcium and iPTH. Conclusion：This interim analysis revealed the ability of ferric citrate hydrate to keep lowering serum phosphate level over one year without any concerns about unexpected adverse drug reactions. It was suggested that ferric citrate hydrate is an useful treatment to manage serum phosphate in hyperphosphatemia patient with CKD.