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Abstract: TH-PO691

Effects of Daprodustat on Hemoglobin and Quality of Life in Non-Dialysis CKD Patients: Expanded Results of the ASCEND-NHQ 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

  • Johansen, Kirsten L., Hennepin Healthcare, University of Minnesota, Minneapolis, Minnesota, United States
  • Finkelstein, Fredric O., Yale University, New Haven, Connecticut, United States
  • Kovesdy, Csaba P., University of Tennessee Health Science Center, Memphis, Tennessee, United States
  • Bhatt, Purav Rahulkumar, GSK, Collegeville, Pennsylvania, United States
  • Israni, Rubeen K., GSK, Collegeville, Pennsylvania, United States
  • Refoios Camejo, Rodrigo, GSK, Brentford, United Kingdom
  • Keeley, Tom J H, GSK, Brentford, United Kingdom
  • Mallett, Stephen, GSK, Brentford, United Kingdom
  • Singh, Ajay K., Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, United States
Background

ASCEND-NHQ (a randomized, double-blind, placebo-controlled trial; NCT03409107) investigated the effects of daprodustat on hemoglobin (Hb) and quality of life in non-dialysis patients with chronic kidney disease (CKD). Daprodustat met primary and secondary endpoints, increasing Hb and improving Short Form-36 Vitality score vs placebo. We report data for the CKD Anemia Questionnaire (CKD-AQ), a new patient-reported outcome measure developed from qualitative patient interviews to specifically capture symptoms related to anemia of CKD.

Methods

The CKD-AQ is a 21-item questionnaire with 3 domains: tired/low energy/weak (10 items), chest pain/shortness of breath (4 items), and cognitive (3 items); and 4 individual items. Items are scored on a scale of 0–100 (worst–best). Patients in ASCEND-NHQ were randomized 1:1 (daprodustat:placebo), to achieve and maintain target Hb (11–12g/dL) over 28 weeks. Changes in scores from baseline to Week 28 were compared between treatments via a linear mixed effect repeated measures model (missing data were not imputed) (Table).

Results

Of 614 patients, 405 (212 daprodustat, 193 placebo) had baseline and on-treatment Week 28 CKD-AQ data. Daprodustat increased Hb vs placebo (1.58 vs 0.19g/dL; mean difference 1.40, 95% confidence interval 1.23–1.56). Patients on daprodustat had significantly greater improvement in all CKD-AQ domains and 1 of 4 individual items vs placebo (Table). Incidence of fatigue and anemia adverse events was higher for placebo vs daprodustat.

Conclusion

Anemia of CKD treatment with daprodustat improved tiredness, chest pain/shortness of breath, and cognition difficulties, often associated with potential productivity loss in patients with anemia of CKD.

Table. Summary of on-treatment change from baseline in CKD-AQ1 domains and individual items in ASCEND-NHQ

Funding

  • Commercial Support