eprintid: 10126153
rev_number: 14
eprint_status: archive
userid: 608
dir: disk0/10/12/61/53
datestamp: 2021-04-19 12:30:53
lastmod: 2021-10-04 01:36:18
status_changed: 2021-04-19 12:30:53
type: article
metadata_visibility: show
creators_name: Singh, AK
creators_name: Blackorby, A
creators_name: Cizman, B
creators_name: Carroll, K
creators_name: Cobitz, AR
creators_name: Davies, R
creators_name: Jha, V
creators_name: Johansen, KL
creators_name: Lopes, RD
creators_name: Kler, L
creators_name: Macdougall, IC
creators_name: McMurray, J
creators_name: Meadowcroft, AM
creators_name: Obrador, GT
creators_name: Perkovic, V
creators_name: Solomon, S
creators_name: Wanner, C
creators_name: Waikar, SS
creators_name: Wheeler, DC
creators_name: Wiecek, A
title: Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial
ispublished: inpress
divisions: UCL
divisions: B02
divisions: C10
divisions: D17
divisions: G93
keywords: anaemia, baseline data, daprodustat, dialysis, recombinant human erythropoietin
note: © The Author(s) 2021. Published by Oxford University Press on behalf of ERA-EDTA.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
abstract: BACKGROUND: The Anemia Studies in chronic kidney disease (CKD): Erythropoiesis via a Novel prolyl hydroxylase inhibitor (PHI) Daprodustat-Dialysis (ASCEND-D) trial will test the hypothesis that daprodustat is non-inferior to comparator epoetin alfa or darbepoetin alfa for two co-primary endpoints: haemoglobin efficacy and cardiovascular safety. METHODS: We report the trial design, key demographic, clinical, and laboratory findings, and baseline therapies of 2964 patients randomised in the open-label (sponsor-blinded) active-controlled, parallel-group, randomised 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 cardiovascular 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 haemoglobin at baseline was 10.4 g/dL. Among randomised patients, 89% were receiving haemodialysis and 11% peritoneal dialysis. Among key co-morbidities, 42% reported a history of diabetes mellitus, and 45% a history of cardiovascular disease. Median blood pressure was 134/74 mmHg. The median weekly dose of epoetin was 5751 units. Intravenous and oral iron use was 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. CONCLUSION: ASCEND-D will evaluate the efficacy and safety of daprodustat compared with epoetin alfa or darbepoetin alfa in the treatment of patients with anaemia with CKD G5D.
date: 2021-03-21
date_type: published
official_url: https://doi.org/10.1093/ndt/gfab065
oa_status: green
full_text_type: other
language: eng
primo: open
primo_central: open_green
verified: verified_manual
elements_id: 1857046
doi: 10.1093/ndt/gfab065
pii: 6179323
lyricists_name: Wheeler, David
lyricists_id: DWHEE12
actors_name: Flynn, Bernadette
actors_id: BFFLY94
actors_role: owner
full_text_status: public
publication: Nephrology Dialysis Transplantation
event_location: England
citation:        Singh, AK;    Blackorby, A;    Cizman, B;    Carroll, K;    Cobitz, AR;    Davies, R;    Jha, V;                                                     ... Wiecek, A; + view all <#>        Singh, AK;  Blackorby, A;  Cizman, B;  Carroll, K;  Cobitz, AR;  Davies, R;  Jha, V;  Johansen, KL;  Lopes, RD;  Kler, L;  Macdougall, IC;  McMurray, J;  Meadowcroft, AM;  Obrador, GT;  Perkovic, V;  Solomon, S;  Wanner, C;  Waikar, SS;  Wheeler, DC;  Wiecek, A;   - view fewer <#>    (2021)    Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial.                   Nephrology Dialysis Transplantation        10.1093/ndt/gfab065 <https://doi.org/10.1093/ndt%2Fgfab065>.    (In press).    Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/10126153/1/gfab065.pdf