Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis

Two randomized, open-label, noninferiority phase 3 trials compared the prolyl hydroxylase inhibitor vadadustat with darbepoetin alfa in patients with incident or prevalent chronic kidney disease who were undergoing dialysis. Vadadustat was noninferior to darbepoetin alfa with respect to cardiovascul...

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Veröffentlicht in:	The New England journal of medicine 2021-04, Vol.384 (17), p.1601-1612
Hauptverfasser:	Eckardt, Kai-Uwe, Agarwal, Rajiv, Aswad, Ahmad, Awad, Ahmed, Block, Geoffrey A, Bacci, Marcelo R, Farag, Youssef M.K, Fishbane, Steven, Hubert, Harold, Jardine, Alan, Khawaja, Zeeshan, Koury, Mark J, Maroni, Bradley J, Matsushita, Kunihiro, McCullough, Peter A, Lewis, Eldrin F, Luo, Wenli, Parfrey, Patrick S, Pergola, Pablo, Sarnak, Mark J, Spinowitz, Bruce, Tumlin, James, Vargo, Dennis L, Walters, Kimberly A, Winkelmayer, Wolfgang C, Wittes, Janet, Zwiech, Rafal, Chertow, Glenn M
Format:	Artikel
Sprache:	eng
Schlagworte:	Adverse events Aged Anemia Anemia - blood Anemia - drug therapy Anemia - etiology Cardiovascular Diseases - chemically induced Cerebral infarction Clinical trials Committees Congestive heart failure Darbepoetin alfa - adverse effects Darbepoetin alfa - therapeutic use Design Dialysis Erythropoietin Female Glycine - adverse effects Glycine - analogs & derivatives Glycine - therapeutic use Heart attacks Heart failure Hematinics - adverse effects Hematinics - therapeutic use Hemoglobin Hemoglobins - analysis Humans Hydroxylase Hypoxia Hypoxia-inducible factors Kidney diseases Male Middle Aged Myocardial infarction Peritoneal dialysis Picolinic Acids - adverse effects Picolinic Acids - therapeutic use Prolyl hydroxylase Prolyl-Hydroxylase Inhibitors - adverse effects Prolyl-Hydroxylase Inhibitors - therapeutic use Renal Dialysis - adverse effects Renal Insufficiency, Chronic - complications Renal Insufficiency, Chronic - mortality Renal Insufficiency, Chronic - therapy Safety Stroke Thromboembolism
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Beschreibung
Zusammenfassung:	Two randomized, open-label, noninferiority phase 3 trials compared the prolyl hydroxylase inhibitor vadadustat with darbepoetin alfa in patients with incident or prevalent chronic kidney disease who were undergoing dialysis. Vadadustat was noninferior to darbepoetin alfa with respect to cardiovascular safety and correction and maintenance of hemoglobin concentrations.
ISSN:	0028-4793 1533-4406
DOI:	10.1056/NEJMoa2025956