ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005


The Latest on X

Kidney Week

Please note that you are viewing an archived section from 2019 and some content may be unavailable. To unlock all content for 2019, please visit the archives.

Abstract: TH-OR022

ROCKIES: An International, Phase 3, Randomized, Open-Label, Active-Controlled Study of Roxadustat for Anemia in Dialysis-Dependent CKD Patients

Session Information

Category: Anemia and Iron Metabolism

  • 202 Anemia and Iron Metabolism: Clinical


  • Fishbane, Steven, Northwell Health, Great Neck, New York, United States
  • Pollock, Carol A., The University of Sydney, Sydney, New South Wales, Australia
  • El-Shahawy, Mohamed A., Keck-USC School of Medicine, Los Angeles, California, United States
  • Escudero, Elizabeth Teresa, Hospital Arzobispo Loayza, Lima, Peru
  • Rastogi, Anjay, University of California Los Angeles, Los Angeles, California, United States
  • Pham van, Bui, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, Viet Nam
  • Frison, Lars, AstraZeneca, Mölndal, Sweden
  • Houser, Mark T., AstraZeneca, Gaithersburg, Maryland, United States
  • Pola, Maksym, AstraZeneca, Warsaw, Poland
  • Guzman, Nicolas Jose, AstraZeneca, Gaithersburg, Maryland, United States
  • Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States

Roxadustat is an oral hypoxia–inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and improves iron absorption and utilization.


This Phase 3 trial evaluated roxadustat vs epoetin alfa (epo) in patients (pts) with ESRD and anemia receiving dialysis. Pts with baseline (BL) hemoglobin (Hb) of <12 g/dL if treated with an erythropoietin analog or <10 g/dL if not were recruited. Pts were randomized 1:1 to receive oral roxadustat or epo. For pts receiving epo at BL, initial roxadustat dose was based on epo dose; for epo-naïve pts initial roxadustat dose was weight-based. Roxadustat dose was constant for first 4 wks; a dose adjustment algorithm for roxadustat (20 mg qw–400 mg tiw to max 3 mg/kg) was used to maintain Hb between 10–12 g/dL. Oral iron was allowed; IV iron was used as standard-of-care in epo arm and with evidence of iron deficiency in roxadustat arm. Primary efficacy endpoint was mean Hb change from BL to Hb averaged over wks 28–52. Roxadustat safety data integrated across multiple appropriate dialysis trials will be reported separately.


2133 dialysis pts were randomized (1068 roxadustat, 1065 epo). Mean age was 54.0 years, 59% male, 57% white. Mean duration of dialysis was 37.5 months, 19.5% were incident pts (2 wks to 4 months). Mean (SD) BL Hb was 10.01 (1.22) g/dL. Mean Hb change from BL to average over wks 28–52 was higher with roxadustat (+0.77 g/dL) vs epo (+0.68 g/dL; p=0.036) in the overall cohort. Mean Hb change from BL to average over wks 28–52 in pts with elevated BL high-sensitivity C-reactive protein (hsCRP) was greater with roxadustat (+0.80 g/dL) vs epo (+0.59 g/dL; p=0.012). Roxadustat-treated pts had Hb ≥10 g/dL for a similar proportion of time over wks 28–52 vs epo-treated pts (79% vs 76%, respectively; p=0.045). Proportion of pts who received red blood cell transfusion was comparable between roxadustat and epo arms (HR=0.83; 95% CI: 0.64–1.07). Roxadustat-treated pts used less monthly IV iron from wk 36 to end of study (58.7 vs 91.4 mg, respectively; p<0.0001).


Roxadustat effectively increased Hb, overall and in pts with elevated hsCRP, and reduced IV iron use in pts with dialysis-dependent CKD.


  • Commercial Support – AstraZeneca