Roxadustat for the treatment of anaemia in chronic kidney disease patients not on dialysis: a Phase 3, randomized, open-label, active-controlled study (DOLOMITES).

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Barratt J, Andric B, Tataradze A, Schomig M, Reusch M, Valluri U, Mariat C

Roxadustat for the treatment of anaemia in chronic kidney disease patients not on dialysis: a Phase 3, randomized, open-label, active-controlled study (DOLOMITES).

Nephrol Dial Transplant. 2021 Aug 27;36(9):1616-1628. doi: 10.1093/ndt/gfab191.

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34077510 [ View in PubMed
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Abstract

BACKGROUND: Roxadustat, an orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor, is being evaluated for treatment of anaemia of chronic kidney disease (CKD). METHODS: This randomized, open-label, active-controlled Phase 3 study compared roxadustat versus darbepoetin alfa (DA) in non-dialysis-dependent (NDD) CKD patients with anaemia for /=11.0 g/dL and Hb change from baseline (BL; CFB) >/=1.0 g/dL in patients with BL Hb >8.0 g/dL or CFB >/=2.0 g/dL in patients with BL Hb

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