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Randomized Controlled Trial
. 2022 Apr 25;37(5):960-972.
doi: 10.1093/ndt/gfab065.

Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial

Ajay K Singh  1 , Allison Blackorby  2 , Borut Cizman  2 , Kevin Carroll  3 , Alexander R Cobitz  2 , Rich Davies  2 , Vivekanand Jha  4   5   6 , Kirsten L Johansen  7 , Renato D Lopes  8 , Lata Kler  2 , Iain C Macdougall  9 , John J V McMurray  10 , Amy M Meadowcroft  2 , Gregorio T Obrador  11 , Vlado Perkovic  12 , Scott Solomon  1 , Christoph Wanner  13 , Sushrut S Waikar  14 , David C Wheeler  15 , Andrzej Wiecek  16
Affiliations
Randomized Controlled Trial

Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial

Ajay K Singh et al. Nephrol Dial Transplant. .

Abstract

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.

Keywords: anemia; baseline data; daprodustat; dialysis; recombinant human erythropoietin.

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Figures

Graphical Abstract
Graphical Abstract
FIGURE 1
FIGURE 1
ASCEND-D study design. Serum and plasma samples are collected at baseline, Week 28 and Week 52 for future analysis of biomarkers of CV risk and iron metabolism.
See this image and copyright information in PMC

References

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    1. Besarab A, Bolton WK, Browne JK. et al. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N Engl J Med 1998; 339: 584–590 - PubMed
    1. Singh AK, Szczech L, Tang KL. et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006; 355: 2085–2098 - PubMed
    1. Drüeke TB, Locatelli F, Clyne N. et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006; 355: 2071–2084 - PubMed

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