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Author: search.filters.author.Cobitz, Alexander R.Subject: search.filters.subject.Anemia

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    Item type:Publication,
    Regional Variation of Erythropoiesis-Stimulating Agent Hyporesponsiveness in the Global Daprodustat Dialysis Study (ASCEND-D)
    (Karger Publishers, 2023)
    Macdougall, Iain C.
    ;
    Meadowcroft, Amy M.
    ;
    Blackorby, Allison
    ;
    Cizman, Borut
    ;
    Cobitz, Alexander R.
    Introduction: Hyporesponsiveness to erythropoiesis-stimulating agents (ESAs) affects 10-15% of the chronic dialysis population. We explored baseline characteristics and predictors of ESA hyporesponsiveness in a global randomized cardiovascular outcomes study comparing an investigational hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), daprodustat, with conventional ESA treatment. Methods: ASCEND-D (NCT02879305) recruited 2,964 chronic dialysis patients receiving ESA treatment (standardized to weekly intravenous [IV] epoetin) who were iron replete at baseline. The primary ESA hyporesponsiveness definition was an ESA Resistance Index (ERI, ESA units/kg/week/hemoglobin g/L) ≥2 or IV standardized ESA dose ≥450 units/kg/week. Predictors of ESA hyporesponsiveness were determined using a multivariable regression model. Alternative hyporesponder definitions were explored. The Author(s). Published by S. Karger AG, Basel.
    Scopus© Citations 6  33
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    Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial
    (2021)
    Singh, Ajay K.
    ;
    Blackorby, Allison
    ;
    Cizman, Borut
    ;
    Carroll, Kevin
    ;
    Cobitz, Alexander R.
    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. © The Author(s) 2021. Published by Oxford University Press on behalf of the ERA-EDTA.
    Scopus© Citations 10  42  1