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Abstract: TH-PO692

Hemoglobin Stability in the ASCEND-D and -ND Trials

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: CKD (Non-Dialysis)

  • 2202 CKD (Non-Dialysis): Clinical‚ Outcomes‚ and Trials

Authors

  • Jha, Vivekanand, George Institute for Global Health, New Delhi, India
  • Johansen, Kirsten L., Hennepin Healthcare, Minneapolis, Minnesota, United States
  • Pergola, Pablo E., Renal Associates, San Antonio, Texas, United States
  • Coyne, Daniel W., Washington University School of Medicine, St. Louis, Missouri, United States
  • St. Ledger, Katie, GSK, Collegeville, Pennsylvania, United States
  • Mallett, Stephen, GSK, Brentford, United Kingdom
  • Bhatt, Purav Rahulkumar, GSK, Collegeville, Pennsylvania, United States
  • Duarte, Maria Eugenia, GSK, Collegeville, Pennsylvania, United States
  • Singh, Ajay K., Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States
Background

Maintaining hemoglobin (Hb) levels in target ranges per clinical care guidelines for patients (pts) with chronic kidney disease (CKD) is complex. We examined Hb stability in pts with CKD on dialysis (ASCEND-D, NCT02879305) or not on dialysis (ASCEND-ND, NCT02876835) treated with daprodustat (Dapro) or erythropoiesis-stimulating agents (ESAs).

Methods

ASCEND-D and -ND were global, open-label, event-driven cardiovascular outcome trials. Our analyses examined the percentage of pts who achieved a mean Hb within the analysis target range (10.0–11.5g/dL); the percentage of time within range in the evaluation period (EP: weeks 28–52) and maintenance period (MP: week 28–end of treatment); Hb excursions (≥12g/dL or <7.5g/dL); Hb increases and decreases >2g/dL during EP. Separate analyses were performed for Dapro and ESA per study.

Results

Of enrolled pts, 2485/2964 (83.8%; ASCEND-D) and 3011/3872 (77.8%; ASCEND-ND) had evaluable Hb during the EP. Hb was within the target range in 903/1238 (73%) Dapro pts and 866/1247 (69%) ESA pts (p=0.0367; ASCEND-D), and 1167/1491 (78%) Dapro pts and 1063/1520 (70%) ESA pts (p<0.0001; ASCEND-ND). In both studies, for Dapro vs ESA, respectively, Hb stayed within the target range for a greater proportion of time (61% vs 59%, p=0.0805 [ASCEND-D]; 71% vs 63%, p<0.0001 [ASCEND-ND]) and a greater proportion of pts exhibited an Hb increase >2g/dL (15% vs 10%, [ASCEND-D]; 10% vs 7% [ASCEND-ND]) (Table). The proportions of Dapro pts achieving target Hb and time in the target Hb range were higher in ASCEND-ND than -D.

Conclusion

In ASCEND-D and-ND, more pts treated with Dapro achieved target Hb and spent more time in the target Hb range than pts treated with ESAs. This suggests that Dapro may provide increased Hb stability vs conventional ESA.

Table. Hb increases and decreases in pts with CKD on dialysis (ASCEND-D) and not on dialysis (ASCEND-ND)

Funding

  • Commercial Support