Akebia Therapeutics and US Renal Care (USRC) have announced plans to begin a collaborative clinical trial of the recently approved Vafseo (vadadustat). The first patient in this trial is expected to be enrolled this year.
The two companies state that the Vafseo Outcomes In-Center Experience (VOICE) trial intends to investigate the safety of three times weekly oral vadadustat for the treatment of anaemia in haemodialysis patients. To do so, they will enrol approximately 2,200 participants who will be randomised to oral Vafseo 300mg tablets administered three times per week or standard-of-care erythropoiesis-stimulating agents.
This trial is an investigator-initiated, multicentre, randomised (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anaemia in in-centre haemodialysis patients with end-stage kidney disease (ESKD). This study will obtain long-term safety data in a large sample of patients receiving in-centre haemodialysis to support adoption of three times per week vadadustat dosing. The trial will end approximately 18 months after the last patient is randomised, with the primary endpoint being all-cause mortality and the secondary endpoint all-cause hospitalisation. The trial was powered to demonstrate non-inferiority for all-cause mortality and superiority for a 10% reduction in all-cause hospitalisation.
“We are pleased to be collaborating with the prominent kidney care provider, US Renal Care, on this important trial. Akebia has already established a robust body of evidence with respect to the safety and efficacy of Vafseo in dialysis patients with the INNO2VATE clinical trial programme, as well as its MO2DIFY and FO2CUS studies,” said Steven K Burke, chief medical officer (CMO) of Akebia. “Given what we have learned, we are excited to collaborate with US Renal Care on the VOICE trial to further investigate the safety of Vafseo when dosed three times a week to align with patients’ current dialysis schedule. We continue to focus on helping those kidney patients who may benefit from an orally administered treatment for anaemia that leads to enhanced haemoglobin stability.”
“US Renal Care is proud to be spearheading the first Vafseo patient experience trial in our dialysis centres,” noted Geoffrey A Block, associate CMO (ACMO) and senior vice president (SVP), clinical research and medical affairs for US Renal Care. “This innovative product has the potential to become the new standard of care for treating anaemia due to chronic kidney disease and it is important to build the body of real-world evidence to understand the potential benefits and risks of treating patients with Vafseo, providing valuable insights for our treating physicians and patient community.”
