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Kidney Week

Abstract: TH-PO685

Causes of Death in Patients With Anemia of CKD (With/Without Diabetes Mellitus) in the ASCEND-ND Trial

Session Information

  • Anemia and Iron Metabolism
    November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Singh, Ajay K., Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States
  • Aarup, Michael, Department of Nephrology, Odense University Hospital, Odense, Denmark
  • Claggett, Brian, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States
  • Cobitz, Alexander Ralph, GSK, Collegeville, Pennsylvania, United States
  • Dobronravov, Vladimir A., Research Institute of Nephrology, Pavlov University, Saint-Petersburg, Russian Federation
  • Hutchison, Colin A., Department of Medicine, Hawke’s Bay District Health Board, Hastings, New Zealand
  • Juillard, Laurent, Université de Lyon, CarMeN, INSERM U1060, INSA de Lyon, Université Claude Bernard Lyon 1, Villeurbanne, France
  • Maes, Bart D., Department of Nephrology, AZ Delta Hospital, Roeselare, Belgium
  • Mallett, Stephen, GSK, Brentford, United Kingdom
  • Pani, Antonello, Divisione di Nefrologia e Dialisi, Azienda Ospedaliera G. Brotzu, Cagliari, Italy
  • Ots-Rosenberg, Mai, Tartu University Hospital, Tartu, Estonia
  • Shaddinger, Bonnie, GSK, Collegeville, Pennsylvania, United States
  • Strutz, Frank M., DKD Helios Klinik Wiesbaden, KfH und Nierenzentrum-Rheumatologie Wiesbaden, Wiesbaden, Germany
  • Vervloet, Marc G., Department of Nephrology, Amsterdam University Medical Center, Amsterdam, Netherlands
  • Wanner, Christoph, University of Würzburg, Würzburg, Germany
  • Wiecek, Andrzej, Department of Nephrology, Transplantation and Internal Medicine, Medical University of Silesia in Katowice, Katowice, Poland
  • McMurray, John, Glasgow University, Glasgow, United Kingdom
Background

Cardiovascular (CV) etiologies, including diabetes mellitus (DM), are the most common cause of death among chronic kidney disease (CKD) patients. This post-hoc analysis of adjudicated causes of death in patients with anemia of CKD with/without DM in the ASCEND-ND trial investigated the safety of daprodustat (Dapro), a hypoxia-inducible factor prolyl hydroxylase inhibitor, for treatment of anemia of CKD in non-dialysis patients.

Methods

ASCEND-ND (NCT02876835) was a global, randomized, open-label, phase 3 CV outcome trial. Patients received daily oral Dapro or subcutaneous darbepoetin alfa (Darbe). Outcomes were centrally adjudicated. Survival data for the intent-to-treat population was analyzed using Kaplan-Meier methods (DM vs non-DM).

Results

Of 3872 randomized patients (DM N=2194, non-DM N=1678), baseline characteristics were broadly balanced across treatment arms, although DM patients were older, had greater body mass index and systolic blood pressure, and more CV disease/CV medication use than non-DM patients. All-cause mortality was significantly higher in DM vs non-DM patients (hazard ratio [HR]=1.87, 95% confidence interval [CI]: 1.57–2.23; Figure 1A); this association did not differ by treatment (HR=1.87 [Dapro] vs 1.86 [Darbe]; p=0.96). Infection and CV mortality each accounted for approximately 30% of deaths independent of DM status (Figure 1B).

Conclusion

In patients with anemia of CKD not on dialysis, the overall death rate was higher in DM patients, but cause of death was similar regardless of DM status; infection in patients with or without DM was the most frequent cause of death.

Figure 1. All-cause mortality* (A) and causes of death (B) in patients with anemia of CKD not on dialysis with/without DM (ITT population)

Funding

  • Commercial Support