New England Journal of Medicine Publishes Results of Global Phase 3 Clinical Program of Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease
Vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is Akebia's lead product candidate. In late
"Having recently submitted our NDA for vadadustat, we are proud to have the results of our global Phase 3 clinical program published in the prestigious
"The kidney community has been eagerly awaiting peer-reviewed publication of comprehensive and straight-forward analyses of cardiovascular safety and hematological efficacy results of a Phase 3 program evaluating the treatment of anemia associated with CKD with a novel HIF-PHI," said
Dr. Chertow is the lead author of the PRO2TECT manuscript titled, "Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD," which states, "Vadadustat, as compared with darbepoetin alfa, met the prespecified noninferiority criterion for hematologic efficacy but not the prespecified noninferiority criterion for cardiovascular safety.
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat recently completed its global Phase 3 clinical development program for the treatment of anemia due to CKD. Vadadustat is not approved by the
About Anemia due to Chronic Kidney Disease (CKD)
Anemia is a condition in which a person lacks enough healthy red blood cells to carry adequate oxygen to the body's tissues. It commonly occurs in people with CKD because their kidneys do not produce enough erythropoietin (EPO), a hormone that helps regulate production of red blood cells. Anemia due to CKD can have a profound impact on a person's quality of life as it can cause fatigue, dizziness, shortness of breath and cognitive dysfunction. Left untreated, anemia leads to deterioration in health and is associated with increased morbidity and mortality in people with CKD.
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