Akebia Announces Manuscript Highlighting Global Phase 3 INNO2VATE Program Rationale, Study Design and Baseline Characteristics Published in Peer-Reviewed Medical Journal
The manuscript, titled "Global Phase 3 programme of vadadustat for treatment of anaemia of chronic kidney disease: rationale, study design and baseline characteristics of dialysis-dependent patients in the INNO2VATE trials," includes a detailed description of design and methodology of the two Phase 3 INNO2VATE trials and summarize demographic and baseline characteristics of randomized patients. Importantly, the manuscript notes that "demographics and baseline characteristics of patients enrolled in the two studies are comparable to those typically observed in patients with DD (dialysis dependent)-CKD, suggesting the results of the INNO2VATE studies will be generalizable to a large proportion of the DD-CKD population."
INNO2VATE evaluated the efficacy and safety of vadadustat, Akebia's investigational oral HIF-PHI, versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis. As previously reported, vadadustat achieved the primary and key secondary efficacy endpoints and the primary safety endpoint of the INNO2VATE program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of a major adverse cardiovascular event (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke across both INNO2VATE studies. In addition, vadadustat achieved non-inferiority to darbepoetin alfa on key secondary safety endpoints that included expanded MACE, cardiovascular MACE, cardiovascular mortality, and all-cause mortality.
"Achieving the first publication of a manuscript on the design of our global Phase 3 program focused on a HIF-PHI for anemia in a well-regarded, peer-reviewed nephrology journal is an important achievement for our company," said
Nephrology Dialysis Transplantation: an international basic science and clinical renal journal (NDT) is the leading nephrology journal in
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 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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