Vadadustat safety profile seen as comparable to that of darbepoetin in patients with CKD

In an evaluation of four phase 3 trials presented at ASN Kidney Week, vadadustat had a comparable treatment-emergent adverse event profile compared with that of darbepoetin alfa for patients with chronic kidney disease.

The analysis compiled safety findings from four global phase 3, randomized, open-label studies that have investigated the use of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, as a treatment of anemia caused by CKD.

Those phase 3 studies evaluated different safety aspects of vadadustat compared with other treatments, such as darbepoetin alfa, in patients with dialysis-dependent and nondialysis-dependent CKD.

In the two INNO2VATE phase three trials, also presented at ASN Kidney Week, iron-related outcomes for vadadustat were compared with darbepoetin in patients on dialysis and those not on dialysis. Both found that treatment with vadadustat decreased hepcidin and ferritin levels and increased total iron-binding capacity.

In the two PRO2TECT phase three trials, presented during a late-breaking session at ASN Kidney Week, vadadustat was evaluated as a treatment for anemia in patients with CKD on dialysis and those not on dialysis.

"The PRO2TECT results show that orally administered vadadustat achieved both primary and secondary efficacy endpoints in patients not on dialysis with anemia associated with CKD. The newly presented analyses showed that there were regional differences with respect to [major adverse cardiovascular events] MACE, expanded MACE and all-cause mortality, consistent with well-known, differing regional hemoglobin treatment target guidelines," Glenn M. Chertow, MD, MPH, professor of medicine, chief of the division of nephrology at Stanford University and co-chair of the independent executive steering committee for PRO2TECT and INNO2VATE, said in a press release.

"The analyses also confirm there was no increased cardiovascular risk associated with vadadustat across the U.S. patients treated to a target hemoglobin range of 10 [g/dL] to 11 g/dL," Chertow said.