US-based biopharmaceutical firm Akebia Therapeutics has started dosing patients in its Phase II FO2RWARD clinical trial of vadadustat for the treatment of patients with dialysis-dependent chronic kidney disease (DD-CKD).
Vadadustat is an investigational, oral stabiliser of hypoxia-inducible factor (HIF) being developed to treat anaemia associated with CKD.
The randomised, open-label Phase II trial is designed to assess the safety and efficacy of the drug in 80 DD-CKD patients who are hyporesponsive to erythropoiesis-stimulating agents (ESAs) compared to epoetin alfa.
According to data from a retrospective analysis conducted in partnership with DaVita Clinical Research, ESA hyporesponse patients showed greater mortality, iron and ESA use, and lower haemoglobin levels when compared to non-ESA hyporesponsive subjects.
Akebia president and chief executive officer John Butler said: “Patients who do not adequately respond to ESA treatment represent approximately 10%-15% of DD-CKD patients, yet hyporesponders account for 30%-40% of total ESA use.
“These patients have demonstrated a persistently higher risk of mortality than non-hyporesponders, and represent a high unmet need.
"We believe that vadadustat may provide a solution for these patients, and we anticipate results from FO2RWARD next year."
The percentage decrease in prior epoetin alfa dose and change in haemoglobin levels during the treatment period will be measured as the trial’s primary outcome.
The results from the Phase II FO2RWARD trial are expected to be available by the end of next year.
Akebia is further investigating vadadustat in a Phase III programme, including PRO2TECT trial on non-dialysis patients with anaemia secondary to CKD and INNO2VATE trial to treat dialysis-dependent patients.