- Ast=Astellas trial
- AZ=AstraZeneca trial
- Fib=Fibrogen trial
- *Darbepoetin-alfa active comparator
- **Subset of patients with >2 weeks and <4 months of dialysis at the time of randomisation
†Epoetin-alfa active comparator
- ††Subset of patients with >4 months of dialysis at the time of randomisation
- ‡Darbepoetin-alfa or epoetin-alfa active comparator
CKD, chronic kidney disease; DD, dialysis-dependent; ESA, erythropoiesis-stimulating agent; Hb, haemoglobin; IV, intravenous; NDD, non-dialysis-dependent.
- EVRENZO SmPC 09.2024 sect. 5.1
- Barratt J, Andric B, Tataradze A et al. 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;36(9):1616–1628.
- Shutov E, Sulowicz W, Esposito C et al. Roxadustat for the treatment of anemia in chronic kidney disease patients not on dialysis: a Phase 3, randomized, double-blind, placebo-controlled study (ALPS). Nephrol Dial Transplant. 2021;36(9):1629–1639.
- Coyne DW, Roger SD, Shin SK et al. Roxadustat for CKD-related Anemia in Non-dialysis Patients. Kidney Int Rep. 2020;6:624–635.
- Fishbane S, El-Shahawy MA, Pecoits-Filho R et al. Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study. J Am Soc Nephrol. 2021;32:737–755.
- Provenzano R, Shutov E, Eremeeva L et al. Roxadustat for anemia in patients with end-stage renal disease incident to dialysis. Nephrol Dial Transplant. 2021;36(9):1717–1730.
- Fishbane S, Pollock CA, El-Shahawy MA et al. Roxadustat Versus Epoetin Alfa for Treating Anemia in Patients with Chronic Kidney Disease on Dialysis: Results from the Randomized Phase 3 ROCKIES Study. J Am Soc Nephrol. 2022;33:850–866.
- Charytan C, Manllo-Karim R, Martin ER et al. A Randomized Trial of Roxadustat in Anemia of Kidney Failure: SIERRAS Study. Kidney Int Rep. 2021;6(7):1829–1839
- Csiky B, Schömig M, Esposito C et al. Roxadustat for the Maintenance Treatment of Anemia in Patients with End-Stage Kidney Disease on Stable Dialysis: A European Phase 3, Randomized, Open-Label, Active-Controlled Study (PYRENEES). Adv Ther. 2021;38(10):5361–5380.