薬理と治療

Abstract

Objectives The objectives of this study were to evaluate safety and efficacy of long−termtreatment with epoetin kappa in renal anemia patients receiving hemodialysis.Method Subjects with renal anemia on hemodialysis receiving a recombinant humanerythropoietin（rHuEPO）treatment were switched from their rHuEPO（epoetin alpha or epoetinbeta）to the same weekly dose of epoetin kappa administered intravenously for 52weeks, with their dosage and dosing frequency adjusted to keep within a target hemoglobin（Hb）range（10.0 g／dL to 12.0 g／dL）wherever possible. Efficacy endpoints were；target Hbmaintenance rate（the proportion of subjects whose hemoglobin value was within the targetHb range）, mean Hb change, and mean weekly dose change.Results The target Hb maintenance rate was 91.6％ at baseline, 83.0％ at Week 12, 83.3％at Week 28 and 85.1％ at Week 52, changing in the range of 78.4 to 92.4％ throughout thetreatment period. There were no great changes in target Hb maintenance rates, and mean Hbvalues were well maintained. Additionally, no great change in either mean Hb values, ormean weekly doses were observed. In safety assessments, adverse events incidences werenearly identical throughout the treatment period, and no clinically significant adverse drugreaction was noted. Nor were any antibodies to either treatment detected.Conclusions Target Hb maintenance rates were good throughout 52 weeks of treatmentperiod, while sustained, stable improvements in anemia were shown. No clinically significantadverse drug reaction was noted with the long−term epoetin kappa administration.（Jpn Pharmacol Ther 2010；38：199−212）KEY WORDS Erythropoietin, Epoetin kappa, Chronic renal failure patients, Hemodialysis,Long−term clinical study