ENCORE: HAEMOGLOBIN STABILITY IN THE ASCEND-D AND -ND TRIALS

ENCORE: HAEMOGLOBIN STABILITY IN THE ASCEND-D AND -ND TRIALS

Neil Boudville^1,2, Vivekanand Jha³, Kirsten Johansen⁴, Pablo Pergola⁵, Daniel Coyne⁶, Katie Ledger⁷, Stephen Mallet⁸, Purav Bhatt⁷, Maria Duarte⁷, Ajay Singh<sup>9,10

1</sup>University of Western Australia, Perth, Western Australia, Australia
²Sir Charles Gairdner Hospital, Perth, Western Australia, Australia
³George Institute for Global Health, New Dehli, India
⁴Hennepin Healthcare, Minneapolis, Minnesota, United States
⁵Renal Associates, San Antonio, Texas, United States
⁶Washington University School of Medicine, St Louis, Missouri, United States
⁷GSK, Collegeville, Pennsylvania, United States
⁸GSK, Brentford, United Kingdom
⁹Brigham and Women’s Hospital, Boston, Massachussetts, United States
¹⁰Harvard Medical School, Boston, Massachusetts, United States

Abstract

BACKGROUND:Maintaining haemoglobin (Hb) levels in target ranges per clinical care guidelines for patients with chronic kidney disease (CKD) is complex.
Aims: To examine Hb stability in patients with CKD on dialysis (ASCEND-D, NCT02879305) or not on dialysis (ASCEND-ND, NCT02876835) treated with daprodustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, or erythropoiesis-stimulating agents (ESAs).

METHODS:ASCEND-D and -ND were global, open-label, event-driven cardiovascular outcome trials. Percentage of patients 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 daprodustat and ESA per study.

RESULTS: Of enrolled patients, 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%) daprodustat patients and 866/1247 (69%) ESA patients (p=0.0367; ASCEND-D), and 1167/1491 (78%) daprodustat patients and 1063/1520 (70%) ESA patients (p<0.0001; ASCEND-ND). In each study for daprodustat vs ESA, respectively, Hb stayed within the target range for a greater proportion of time (ASCEND-D: 61% vs 59%, p=0.0805; ASCEND-ND:71% vs 63%, p<0.0001)and a greater proportion of patients exhibited an Hb increase >2g/dL (ASCEND-D: 15% vs 10%,; ASCEND-ND: 10% vs 7%) .The proportions of daprodustat patients achieving target Hb and time in the target Hb range were higher in ASCEND-ND than -D.

CONCLUSIONS: In ASCEND-D/-ND, more pts treated with daprodustat achieved target Hb and spent more time in the target Hb range than patients treated with ESAs. This suggests that daprodustat may provide improved Hb stability vs conventional ESA.

Funding: GSK [study#200807-8]

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