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 2021 and some content may be unavailable. To unlock all content for 2021, please visit the archives.

Abstract: FR-OR53

Effects of Daprodustat on Hemoglobin and Quality of Life in Patients with CKD: Results of the ASCEND-NHQ Randomized, Double-Blind, Placebo-Controlled Trial

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism


  • Johansen, Kirsten L., Hennepin Healthcare, University of Minnesota, Minneapolis, Minnesota, United States
  • Cobitz, Alexander Ralph, GlaxoSmithKline, Collegeville, Pennsylvania, United States
  • Lopes, Renato D., Duke Clinical Research Institute, Duke Health, Durham, North Carolina, United States
  • Singh, Ajay K., Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States
  • Obrador, Gregorio T., Universidad Panamericana School of Medicine, Mexico City, Mexico
  • Cizman, Borut, GlaxoSmithKline, Collegeville, Pennsylvania, United States
  • Macdougall, Iain C., King’s College Hospital, London, United Kingdom
  • Okoro, Tony, GlaxoSmithKline, Collegeville, Pennsylvania, United States
  • Sprys, Michael, GlaxoSmithKline, Collegeville, Pennsylvania, United States
  • Jha, Vivekanand, George Institute for Global Health, New Delhi, India
  • Jolly, Shivinder Singh, Clinical Research Solutions Inc, Waterloo, Ontario, Canada
  • Israni, Rubeen K., GlaxoSmithKline, Collegeville, Pennsylvania, United States
  • Kovesdy, Csaba P., University of Tennessee Health Science Center, Memphis, Tennessee, United States
  • Wheeler, David C., Department of Renal Medicine, University College London, London, United Kingdom

Daprodustat (dapro) is a hypoxia-inducible factor prolyl hydroxylase inhibitor being developed for treating anemia of chronic kidney disease (CKD). In a Phase 3 trial in non-dialysis dependent (ND) CKD patients, we evaluated the effect of dapro vs placebo (PBO) on hemoglobin (Hb) and the SF-36 quality of life Vitality score (fatigue) over 28 weeks.


Adults with CKD stage 3–5, Hb 8.5–10.0 g/dL, transferrin saturation ≥15%, ferritin ≥50 ng/ml without recent rhEPO use were randomized 1:1 to dapro or PBO to maintain Hb 11–12 g/dL (NCT03409107). Primary endpoint was mean change in Hb between baseline (BL) and the evaluation period (mean over Wk 24–28). Principal secondary endpoints were 1) proportion with ≥1 g/dL increase in Hb, 2) mean change in SF-36 Vitality (fatigue) between BL and Wk 28. SF-36 Vitality responder (≥6 point increase) and blood pressure (BP) elevations were secondary endpoints. Superiority for all endpoints was tested (1-sided α=0.025).


614 ND-CKD patients were randomized. BL demographic characteristics were balanced; Hb was similar (9.73 g/dL dapro, 9.71 g/dL PBO). The adjusted mean difference (AMD) in change in Hb was 1.40 g/dL (95% CI 1.23, 1.56; P<0.001). A greater proportion on dapro had a ≥1 g/dL increase in Hb from BL (77% vs 18%; P<0.001). Adjusted mean (SE) SF-36 Vitality score increased by 7.3 (1.1) points (dapro) vs 1.9 (1.2) points (PBO); AMD at Wk 28 was 5.4 (95% CI 2.2, 8.6; P<0.001, Figure). 58% on dapro vs 40% on PBO were SF-36 Vitality responders (difference 13%; 95% CI 4%, 22%). While more BP elevations occurred in dapro vs PBO (32% vs 26%, p=0.07), dapro's overall effect on BP was similar to PBO. Rates of adverse events were similar (dapro 69% vs PBO 71%).


In patients with ND-CKD, dapro effectively increased Hb, significantly improved the vitality score (fatigue) and was well tolerated.


  • Commercial Support – GlaxoSmithKline