Evidence map›Paper›PMID 34865143›Full record

ArticleNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2022

The ASCEND-ND trial: study design and participant characteristics.

Vlado Perkovic, Allison Blackorby, Borut Cizman, Kevin Carroll, Alexander R Cobitz, Rich Davies, Tara L DiMino, Vivekanand Jha, Kirsten L Johansen, Renato D Lopes and 12 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02876835 (A Phase 3 Randomized, Open-label), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02876835 phase3completednot on this map

A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa

TypeinterventionalSponsorGlaxoSmithKlineRan2016 to 2021Enrolled3,872ConditionsAnaemiaArmsDaprodustat, Darbepoetin alfa, Placebo, Iron Therapy
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. Daprodustat.Hospital pharmacy · 2023
    Review
  7. Analysis of on-treatment cancer safety events with daprodustat versus conventional erythropoiesis-stimulating agents-post hoc analyses of the ASCEND-ND and ASCEND-D trials.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 14 institutions in 7 countries.

Vlado PerkovicUniversity of New South Wales, Sydney, NSW, Australia.
Allison BlackorbyGlaxoSmithKline, Collegeville, PA, USA.
Borut CizmanGlaxoSmithKline, Collegeville, PA, USA.
Kevin CarrollKJC Statistics, Cheshire, UK.
Alexander R CobitzGlaxoSmithKline, Collegeville, PA, USA.
Rich DaviesGlaxoSmithKline, Collegeville, PA, USA.
Tara L DiMinoGlaxoSmithKline, Collegeville, PA, USA.
Vivekanand JhaGeorge Institute for Global Health, New Delhi, India.
Kirsten L JohansenHennepin Healthcare, University of Minnesota, Minneapolis, MN, USA.
Renato D LopesDuke Clinical Research Institute, Duke Health, Durham, NC, USA.
Lata KlerGlaxoSmithKline, Collegeville, PA, USA.
Iain C MacdougallKing's College Hospital, London, UK.ORCID 0000-0001-9804-0657
John J V McMurrayBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, UK.ORCID 0000-0002-6317-3975
Amy M MeadowcroftGlaxoSmithKline, Collegeville, PA, USA.
Gregorio T ObradorUniversidad Panamericana School of Medicine, Mexico City, Mexico.
Scott SolomonBrigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Lin TaftGlaxoSmithKline, Collegeville, PA, USA.
Christoph WannerUniversity of Würzburg, Würzburg, Germany.
Sushrut S WaikarBoston University School of Medicine and Boston Medical Center, Boston, MA, USA.
David C WheelerDepartment of Renal Medicine, University College London, London, UK.
Andrzej WiecekMedical University of Silesia, Katowice, Poland.
Ajay K SinghBrigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
GlaxoSmithKline (United States) · USBrigham and Women's Hospital · USBoston University · USBritish Heart Foundation · GBCheshire West and Chester · GBClinical Research Institute · USKing's College Hospital · GBManipal Academy of Higher Education · INMedical University of Silesia · PLUniversidad Panamericana · MXUniversity College London · GBUniversity of Minnesota · USUniversity of Würzburg · DEUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnaemia is common in chronic kidney disease (CKD) and assessment of the risks and benefits of new therapies is important.

methodsThe Anaemia Study in CKD: Erythropoiesis via a Novel prolyl hydroxylase inhibitor Daprodustat-Non-Dialysis (ASCEND-ND) trial includes adult patients with CKD Stages 3-5, not using erythropoiesis-stimulating agents (ESAs) with screening haemoglobin (Hb) 8-10 g/dL or receiving ESAs with screening Hb of 8-12 g/dL. Participants were randomized to daprodustat or darbepoetin alfa (1:1) in an open-label trial (steering committee- and sponsor-blinded), with blinded endpoint assessment. The co-primary endpoints are mean change in Hb between baseline and evaluation period (average over Weeks 28-52) and time to first adjudicated major adverse cardiovascular (CV) event. Baseline characteristics were compared with those of participants in similar anaemia trials.

resultsOverall, 3872 patients were randomized from 39 countries (median age 67 years, 56% female, 56% White, 27% Asian and 10% Black). The median baseline Hb was 9.9 g/dL, blood pressure was 135/74 mmHg and estimated glomerular filtration rate was 18 mL/min/1.73 m2. Among randomized patients, 53% were ESA non-users, 57% had diabetes and 37% had a history of CV disease. At baseline, 61% of participants were using renin-angiotensin system blockers, 55% were taking statins and 49% were taking oral iron. Baseline demographics were similar to those in other large non-dialysis anaemia trials.

conclusionASCEND-ND will define the efficacy and safety of daprodustat compared with darbepoetin alfa in the treatment of patients with anaemia associated with CKD not on dialysis.

Indexed as

AnemiaErythropoietinHematinicsHydroxymethylglutaryl-CoA Reductase InhibitorsProlyl-Hydroxylase InhibitorsRenal Insufficiency, ChronicAgedDarbepoetin alfaFemaleHemoglobinsHumansIronMaleRandomized Controlled Trials as TopicRenal DialysisDarbepoetin alfaErythropoietinHematinicsHemoglobinsHydroxymethylglutaryl-CoA Reductase InhibitorsIronProlyl-Hydroxylase Inhibitorsanaemiabaseline datachronic kidney diseasedaprodustat, darbepoetin alfa

Identifiers

PMID34865143
PMCPMC9585467
OpenAlexW4200001459

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.