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Roxadustat for the treatment of anaemia in chronic kidney disease patients not on dialysis: A phase 3, randomised, open-label, active-controlled study (DOLOMITES)

Nephrology Dialysis Transplantation Jun 09, 2021

Barratt J, Andric B, Tataradze A, et al. - Among non–dialysis-dependent (NDD) chronic kidney disease (CKD) patients with anaemia, a comparison was performed between roxadustat (an orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor) vs darbepoetin alfa (DA) for ≤104 weeks, in this randomised, open-label, active-controlled phase 3 study in order to eventually assess roxadustat as a treatment option for anaemia of CKD. To correct and maintain haemoglobin within 10.0–12.0 g/dL, titration of doses was implemented. Roxadustat showed a noninferior haemoglobin response compared with DA. Haemoglobin was maintained for up to 2 years by roxadustat. In terms of change in mean arterial pressure and time to occurrence of hypertension, roxadustat was found noninferior to DA, but the former was superior to the latter for change in low-density lipoprotein and time to first intravenous iron use. Comparable safety profiles were evident between groups. Overall, roxadustat maintained haemoglobin levels for up to 104 weeks in NDD CKD patients with anemia and thus, represents a viable option for treating anemia in these cases.

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