Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
GlaxoSmithKline, Collegeville, PA, USA.
Nephrol Dial Transplant. 2022 Apr 25;37(5):960-972. doi: 10.1093/ndt/gfab065.
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.
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.
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.
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.
慢性肾脏病（CKD）贫血研究：通过新型脯氨酰羟化酶抑制剂 daprodustat-透析（ASCEND-D）试验将检验以下假设，即 daprodustat 在两个主要终点方面非劣效于对照 epoetin alfa 或 darbepoetin alfa：血红蛋白（Hb）疗效和心血管（CV）安全性。
我们报告了试验设计、关键人口统计学、临床和实验室发现以及 2964 名随机接受开放性（申办方设盲）活性对照、平行组、随机 ASCEND-D 临床试验的患者的基线治疗情况。我们还比较了 ASCEND-D 患者与其他大型 CV 结局试验（CVOT）和最相关登记处中接受透析（CKD G5D）的患者的基线特征。
患者的中位年龄为 58 岁，43%为女性；67%为白人，16%为黑人。基线时的中位 Hb 为 10.4g/dL。在随机分组的患者中，89%接受血液透析，11%接受腹膜透析。在主要合并症中，42%有糖尿病史，45%有 CV 病史。中位血压为 134/74mmHg。中位 epoetin 每周剂量为 5751 单位。分别有 64%和 11%的患者使用静脉铁和口服铁。基线人口统计学特征与其他 CVOT 和肾脏患者登记处中接受 CKD G5D 治疗的患者相似。
ASCEND-D 将评估 daprodustat 与 epoetin alfa 或 darbepoetin alfa 治疗 CKD G5D 贫血患者的疗效和安全性。该试验在 ClinicalTrials.gov 注册：NCT02879305。EudraCT 编号：2016-000541-31；赞助商方案编号：200807。
