Vadadustat in Patients with Anemia and Non–Dialysis-Dependent CKD

Two randomized, phase 3, open-label noninferiority trials compared vadadustat with darbepoetin alfa in patients with non–dialysis-dependent chronic kidney disease. Vadadustat, as compared with darbepoetin alfa, met the prespecified noninferiority criterion for hematologic efficacy but not for cardio...

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Veröffentlicht in:	The New England journal of medicine 2021-04, Vol.384 (17), p.1589-1600
Hauptverfasser:	Chertow, Glenn M, Pergola, Pablo E, Farag, Youssef M.K, Agarwal, Rajiv, Arnold, Susan, Bako, Gabriel, Block, Geoffrey A, Burke, Steven, Castillo, Fausto P, Jardine, Alan G, Khawaja, Zeeshan, Koury, Mark J, Lewis, Eldrin F, Lin, Tim, Luo, Wenli, Maroni, Bradley J, Matsushita, Kunihiro, McCullough, Peter A, Parfrey, Patrick S, Roy-Chaudhury, Prabir, Sarnak, Mark J, Sharma, Amit, Spinowitz, Bruce, Tseng, Carol, Tumlin, James, Vargo, Dennis L, Walters, Kimberly A, Winkelmayer, Wolfgang C, Wittes, Janet, Eckardt, Kai-Uwe
Format:	Artikel
Sprache:	eng
Schlagworte:	Administration, Oral Aged Anemia Anemia - blood Anemia - drug therapy Anemia - etiology Cardiovascular Diseases - chemically induced Cerebral infarction Clinical trials Collaboration Confidence intervals Congestive heart failure Darbepoetin alfa - adverse effects Darbepoetin alfa - therapeutic use Design Dialysis Drug dosages Erythropoiesis Erythropoietin Female Glycine - adverse effects Glycine - analogs & derivatives Glycine - therapeutic use Heart attacks Heart failure Hematinics - adverse effects Hematinics - therapeutic use Hemodialysis Hemoglobin Hemoglobins - analysis Hospitalization - statistics & numerical data Humans Hydroxylase Hypoxia Hypoxia-inducible factors Kidney diseases Male Middle Aged Myocardial infarction Patients Picolinic Acids - adverse effects Picolinic Acids - therapeutic use Prolyl hydroxylase Prolyl-Hydroxylase Inhibitors - adverse effects Prolyl-Hydroxylase Inhibitors - therapeutic use Renal Insufficiency, Chronic - complications Renal Insufficiency, Chronic - mortality Safety Thromboembolism
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Beschreibung
Zusammenfassung:	Two randomized, phase 3, open-label noninferiority trials compared vadadustat with darbepoetin alfa in patients with non–dialysis-dependent chronic kidney disease. Vadadustat, as compared with darbepoetin alfa, met the prespecified noninferiority criterion for hematologic efficacy but not for cardiovascular safety.
ISSN:	0028-4793 1533-4406
DOI:	10.1056/NEJMoa2035938