Vadadustat noninferior, safe compared to darbepoetin alfa
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Vadadustat demonstrated the efficacy and cardiovascular safety for the treatment of anemia in adult patients with dialysis-dependent chronic kidney disease, according to recently presented data.
“Vadadustat was noninferior to darbepoetin alfa with respect to cardiovascular safety and hematologic efficacy in patients on dialysis,” Kai-Uwe Eckardt, MD, said of the clinical results from the global INNO2VATE phase 3 program presented data at ASN Kidney Week.
Researchers conducted two randomized, phase 3 global clinical trials in which they compared vadadustat and darbepoetin alfa for the treatment of anemia in patients with dialysis-dependent CKD. Overall, 3,923 patients were randomized 1:1 to vadadustat or darbepoetin alfa.
The trials included an incident trial for patients new to dialysis and a prevalent trial for patients on maintenance dialysis. Primary safety endpoint was time to first major adverse cardiovascular event (MACE), which was a pooled analysis of both trials. Primary and key secondary efficacy endpoints, which were separate analyses for each trial, were mean difference in hemoglobin from baseline to weeks 24 to 36 and weeks 40 to 52. Median follow-up was 1.2 in the incident trial and 1.7 years in the prevalent trial.
Eckhardt said vadadustat was found to be noninferior to darbepoetin alfa for the time to MACE.
For patients in the incident trial, the mean difference in hemoglobin change between vadadustat vs. darbepoetin alfa from baseline to weeks 24 to 36 was -0.31 g/dL and -0.07 g/dL from baseline to weeks 40 to 52. In the prevalent trial, the mean difference in change in hemoglobin from baseline to weeks 24 to 36 was -0.17 g/dL and -0.18 g/dL for weeks 40 to 52.
In the incident trial, the incidence of treatment-emergent adverse events for patients who received vadadustat was 83.8% compared with 85.5% for patients who received darbepoetin alfa. In the prevalent trial, the incidence of treatment-emergent adverse events for patients who received vadadustat was 88.3% and 89.3% for patients who received darbepoetin alfa.
“The INNO2VATE trials show that oral could be used in patients with dialysis-dependent CKD in place of darbpoetin alfa without increased cardiovascular risk,” Eckardt said.
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Eckardt K, et al. Paper TH-OR01. Presented at: ASN Kidney Week. Oct. 22-25, 2020 (virtual meeting).
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