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

Publication ,  Journal Article
Singh, AK; Blackorby, A; Cizman, B; Carroll, K; Cobitz, AR; Davies, R; Jha, V; Johansen, KL; Lopes, RD; Kler, L; Macdougall, IC; McMurray, JJV ...
Published in: Nephrol Dial Transplant
April 25, 2022

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.

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Published In

Nephrol Dial Transplant

DOI

EISSN

1460-2385

Publication Date

April 25, 2022

Volume

37

Issue

5

Start / End Page

960 / 972

Location

England

Related Subject Headings

  • Urology & Nephrology
  • Renal Insufficiency, Chronic
  • Renal Dialysis
  • Recombinant Proteins
  • Middle Aged
  • Male
  • Humans
  • Hemoglobins
  • Hematinics
  • Female
 

Citation

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Singh, A. K., Blackorby, A., Cizman, B., Carroll, K., Cobitz, A. R., Davies, R., … Wiecek, A. (2022). Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. Nephrol Dial Transplant, 37(5), 960–972. https://doi.org/10.1093/ndt/gfab065
Singh, Ajay K., Allison Blackorby, Borut Cizman, Kevin Carroll, Alexander R. Cobitz, Rich Davies, Vivekanand Jha, et al. “Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial.Nephrol Dial Transplant 37, no. 5 (April 25, 2022): 960–72. https://doi.org/10.1093/ndt/gfab065.
Singh AK, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, et al. Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. Nephrol Dial Transplant. 2022 Apr 25;37(5):960–72.
Singh, Ajay K., et al. “Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial.Nephrol Dial Transplant, vol. 37, no. 5, Apr. 2022, pp. 960–72. Pubmed, doi:10.1093/ndt/gfab065.
Singh AK, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Perkovic V, Solomon S, Wanner C, Waikar SS, Wheeler DC, Wiecek A. Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. Nephrol Dial Transplant. 2022 Apr 25;37(5):960–972.
Journal cover image

Published In

Nephrol Dial Transplant

DOI

EISSN

1460-2385

Publication Date

April 25, 2022

Volume

37

Issue

5

Start / End Page

960 / 972

Location

England

Related Subject Headings

  • Urology & Nephrology
  • Renal Insufficiency, Chronic
  • Renal Dialysis
  • Recombinant Proteins
  • Middle Aged
  • Male
  • Humans
  • Hemoglobins
  • Hematinics
  • Female