BACKGROUND: The Anemia Studies in chronic kidney disease (CKD): Erythropoiesis 
via a Novel prolyl hydroxylase inhibitor Daprodustat-Dialysis (ASCEND-D) trial 
will test the hypothesis that daprodustat is noninferior to comparator epoetin 
alfa or darbepoetin alfa for two co-primary endpoints: hemoglobin (Hb) efficacy 
and cardiovascular (CV) safety.
METHODS: We report the trial design, key demographic, clinical and laboratory 
findings, and baseline therapies of 2964 patients randomized in the open-label 
(sponsor-blinded) active-controlled, parallel-group, randomized ASCEND-D 
clinical trial. We also compare baseline characteristics of ASCEND-D patients 
with patients who are on dialysis (CKD G5D) enrolled in other large CV outcome 
trials (CVOTs) and in the most relevant registries.
RESULTS: The median age of patients was 58 years, 43% were female; 67% were 
White and 16% were Black. The median Hb at baseline was 10.4 g/dL. Among 
randomized patients, 89% were receiving hemodialysis and 11% peritoneal 
dialysis. Among key comorbidities, 42% reported a history of diabetes mellitus 
and 45% a history of CV disease. Median blood pressure was 134/74 mmHg. The 
median weekly dose of epoetin was 5751 units. Intravenous and oral iron uses 
were noted in 64 and 11% of patients, respectively. Baseline demographics were 
similar to patients with CKD G5D enrolled in other CVOTs and renal patient 
registries.
CONCLUSIONS: ASCEND-D will evaluate the efficacy and safety of daprodustat 
compared with epoetin alfa or darbepoetin alfa in the treatment of patients with 
anemia with CKD G5D.This trial is registered with ClinicalTrials.gov: 
NCT02879305. EudraCT Number: 2016-000541-31; Sponsor Protocol Number: 200807.