%0 Generic %A C., Dias %A K.T., Moore %A J., Murphy %A J., Ariyawansa %A W., Smith %A R.M., Mills %A M.R., Weir %D 2017 %T Erratum: Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Rivaroxaban in Chronic Hemodialysis %U https://karger.figshare.com/articles/dataset/Erratum_Pharmacokinetics_Pharmacodynamics_and_Safety_of_Single-Dose_Rivaroxaban_in_Chronic_Hemodialysis/5241970 %R 10.6084/m9.figshare.5241970.v1 %2 https://karger.figshare.com/ndownloader/files/8956711 %K Anticoagulant %K Factor Xa inhibitor %K Rivaroxaban %K End-stage renal disease %K Hemodialysis %K Pharmacokinetics %K Pharmacodynamics %X Background: This study aimed to characterize the single-dose pharmacokinetic (PK) and pharmacodynamic (PD) profile of rivaroxaban 15 mg administered before and after dialysis in subjects with end-stage renal disease (ESRD), and to compare this profile in subjects with ESRD to that in healthy control subjects (creatinine clearance ≥80 ml/min). Methods: This was an open-label, single-dose, single-center, parallel-group study of rivaroxaban in ESRD subjects who had been clinically stable on maintenance hemodialysis for ≥3 months. In 8 subjects with ESRD, a 15-mg dose of rivaroxaban was administered 2 ± 0.5 h before a hemodialysis session and repeated 7-14 days later at 3 h after a 4-h hemodialysis session. Eight healthy control subjects, matched for age, sex, and body mass index, received one 15-mg rivaroxaban dose. Results: Compared to healthy subjects, area under the rivaroxaban plasma concentration versus time curve (AUC) increased by 56% following post-dialysis administration. Assuming similar bioavailability between groups, this reflects an approximate 35% decrease in overall drug clearance in ESRD subjects. Pre-dialysis dosing resulted in only 5% lowering of AUC versus post-dialysis dosing, confirming the minimal impact of dialysis on the PK of rivaroxaban. PD effects, as assessed by change in prothrombin time, percent factor Xa inhibition, and anti-Xa activity, were generally concordant with observed changes in plasma PK. Conclusions: Changes in PK and PD parameters in chronic dialysis patients were generally comparable to changes observed previously in patients with moderate-to-severe renal impairment who were not undergoing dialysis, and support use of a 15-mg dose in this patient population. %I Karger Publishers