Renal impairment limits DOAC use. Studies supporting Food and Drug Administration (FDA)-approval for apixaban did not include patients with a creatinine clearance < 25 mL/min. Consequently, limited guidance for use in end-stage renal disease (ESRD) exists in the package insert...
in apixaban concentrations (peak experimental 315.19 +/- 157.53ng/ml vs control 207.6 +/- 83.38ng/ml; p = 0.08 and trough experimental 182.03 +/- 95.93ng/ml vs control 112.32 +/- 37.78ng/ml; p=0.17) suggesting the need to assess dose adjustment for patients per the FDA package insert....