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

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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).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)Conclusions: 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. Funding: Commercial Support - This study was funded by GSK.

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