US-based biopharmaceutical company Akebia Therapeutics has started the global Phase III programme INNO2VATE to test vadadustat for a second indication to treat renal anemia.
Vadadustat is an oral hypoxia-inducible factor (HIF) stabiliser indicated to treat anemia related to chronic kidney disease (CKD).
It uses the same mechanism as the body to naturally adapt to lower oxygen availability associated with an increase in altitude.
The body increases the production of HIF to respond to lower oxygen availability as the person scales higher altitudes.
It coordinates the interdependent processes of iron mobilisation and erythropoietin production in order to accelerate red blood cell production and thereby improve oxygen delivery.
The INNO2VATE programme includes two separate studies, the INNO2VATE-Correction study and the INNO2VATE-Conversion study.
The INNO2VATE-Correction study is designed to evaluate patients who are not currently being treated with recombinant erythropoiesis stimulating agents (rESAs), while the INNO2VATE-Conversion study will evaluate patients currently receiving rESA.
Both of the open-label, active-control, non-inferiority designed trials will include about 2,600 dialysis-dependent patients with anemia related to CKD.
The INNO2VATE programme primarily focuses at determining the efficacy of vadadustat in inducing the hemoglobin response and an assessment of cardiovascular safety evaluated on the basis of standard major adverse cardiovascular events (MACE) criteria.
Akebia president and CEO John Butler said: “The launch of the INNO2VATE programme represents an important milestone for our global vadadustat Phase III programme.
“Similar to our parallel Phase III PRO2TECT programme in patients who are not currently on dialysis, INNO2VATE is designed to demonstrate the best-in-class potential of vadadustat to treat patients who are suffering from anemia related to chronic kidney disease.”
Akebia’s Phase III PRO2TECT programme is evaluating non-dialysis dependent patients with anemia related to chronic kidney disease and was initiated at the end of last year.