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The EVRENZO “ALPINE” clinical efficacy programme1

A comprehensive range of EVRENZO clinical trials involving 9,600 patients1

Included patients with non-dialysis-dependent, incident dialysis-dependent, and stable dialysis-dependent CKD.1

Evidence_graph
  • 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.

Reference

  • 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.

Reference

  • EVRENZO SmPC 09.2024 sect. 5.1