Differences in ferumoxytol pharmacokinetics (PK) were observed between healthy subjects and chronic kidney disease (CKD) patients on haemodialysis.

Population PK (popPK) approach identified haemodialysis to be the plausible sole cause of the difference between populations.

As no additional PK difference between healthy volunteers and CKD patients was identified, bridging PK to the all-cause iron-deficiency anaemia population using popPK analysis results was accepted by regulators.