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Abstract: TH-PO688

Efficacy and Cardiovascular Safety of Daprodustat for the Management of Renal Anemia in Peritoneal Dialysis Patients: A Prespecified Analysis of the ASCEND-D 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

  • Dasgupta, Indranil, University Hospitals of Birmingham NHS Foundation Trust, Birmingham, United Kingdom
  • Mallett, Stephen, GSK, Brentford, United Kingdom
  • Bhatt, Purav Rahulkumar, GSK, Collegeville, Pennsylvania, United States
  • Acharya, Anjali, Albert Einstein College of Medicine, Bronx, New York, United States
  • Aarup, Michael, Odense University Hospital, Odense, Denmark
  • Correa-Rotter, Ricardo, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
  • Gupta, Shruti, Brigham and Women’s Hospital, Boston, Massachusetts, United States
  • Kher, Vijay K., Medanta Kidney and Urology Institute, Medanta Hospital, South Delhi, India
  • Vieira Neto, Osvaldo Merege, Sociedade Brasileira de Nefrologia, São Paulo, Brazil
  • Rastogi, Anjay, David Geffen School of Medicine UCLA, Los Angeles, California, United States
  • Ots-Rosenberg, Mai, Tartu University Hospital, Tartu, Estonia
  • Rayner, Brian, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa
  • Wong, Muh Geot, University of Sydney, Sydney, New South Wales, Australia
  • Singh, Ajay K., Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, United States
Background

Daprodustat (Dapro), an oral investigational hypoxia-inducible factor prolyl hydroxylase inhibitor, has been shown to be noninferior to conventional erythropoietin stimulating agents in renal anemia treatment of dialysis and non-dialysis patients (pts). This pre-specified subgroup analysis of the ASCEND-D trial examined the efficacy and cardiovascular (CV) safety of Dapro vs darbepoetin-alfa (Darbe) in end-stage kidney disease (ESKD) pts receiving peritoneal dialysis (PD).

Methods

ASCEND-D (NCT02879305) was an open-label, phase 3 trial in ESKD pts on dialysis with screening hemoglobin (Hb) 8.0–11.5g/dL, randomized to Dapro or Darbe. Primary outcomes were mean Hb change from baseline to wks 28 through 52 (noninferiority [NI] margin -0.75g/dL) and first occurrence of a major adverse CV event (MACE: a composite of death from any cause, nonfatal myocardial infarction [MI], or nonfatal stroke [NI margin 1.25]). Mean Hb change was analyzed via an analysis of covariance model adjusting for baseline Hb, treatment, dialysis modality, and geographic region. MACE was analyzed via a Cox proportional-hazards model adjusting for treatment, dialysis modality, and geographic region.

Results

Overall, 340 PD pts (Dapro n=171; Darbe n=169) were randomized (baseline [Dapro/Darbe]: mean age, years [54/53]; % male [56/54]; % dialysis vintage >5 years [18/22]; Hb, g/dL [10.25/10.23]; % stroke [5/5]; and % MI [8/7]). For Dapro and Darbe respectively, the mean change in Hb was 0.38 and 0.23g/dL (adjusted mean difference 0.15 95% confidence interval [CI] -0.04–0.34); a first occurrence of adjudicated MACE occurred in 40 (23.4%) and 46 (27.2%) pts (hazard ratio 0.84 95% CI 0.55–1.28) and the mean average monthly iron dose was 59.6g and 62.9g (adjusted mean difference -3.3 95% CI -30.7–24.0). There was no heterogeneity between PD and hemodialysis pts for these endpoints. Peritonitis rates were 26% (Dapro) and 22% (Darbe).

Conclusion

This pre-specified sub-group analysis of the ASCEND-D trial demonstrates comparable efficacy and CV safety of Dapro vs Darbe in PD pts, supporting use of this novel oral agent in anemic PD pts.

Funding

  • Commercial Support