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Abstract: PO0464

Vadadustat for Treatment of Anemia in Patients with Dialysis-Dependent CKD Receiving Peritoneal Dialysis

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Chertow, Glenn Matthew, Stanford University School of Medicine, Stanford, California, United States
  • Boudville, Neil, The University of Western Australia Medical School, Perth, Western Australia, Australia
  • Chowdhury, Pradip, Peritoneal Dialysis Center of America, Montebello, California, United States
  • Gonzalez, Carlos, PIH Health Inc, Whittier, California, United States
  • Kooienga, Laura, Colorado Kidney Care, Denver, Colorado, United States
  • Luo, Wenli, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Maroni, Brad, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Ntoso, K. Adu, Pennsylvania Nephrology Associates, Philadelphia, Pennsylvania, United States
  • Vargo, Dennis, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Eckardt, Kai-Uwe, Charité – Universitätsmedizin Berlin, Berlin, Germany
Background

Vadadustat (VADA) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor being investigated for treatment of anemia due to chronic kidney disease (CKD). In two recently completed global phase 3 trials in patients with dialysis-dependent CKD (DD-CKD) (INNO2VATE), VADA was noninferior to darbepoetin alfa (DA) for the primary safety endpoint (time to first major adverse cardiovascular event [MACE: a composite of all-cause mortality, nonfatal MI, and nonfatal stroke]) and the primary and secondary efficacy endpoints (correction/maintenance of hemoglobin [Hb]).

Here we describe safety and efficacy of VADA compared to DA in the subgroup of patients receiving peritoneal dialysis (PD).

Methods

We conducted two randomized (1:1), phase 3, global, open-label, sponsor-blind, parallel-group active-controlled noninferiority trials (INNO2VATE) comparing VADA vs DA to determine safety and efficacy in patients with anemia of DD-CKD receiving dialysis (either PD or hemodialysis). The prespecified primary safety endpoint was time to first MACE, defined as all-cause mortality or nonfatal myocardial infarction or stroke. The primary and key secondary efficacy endpoints were the mean change in Hb from baseline to wk 24–36 and from baseline to wk 40–52, respectively, in each trial. We assessed the incidence of treatment-emergent adverse events (TEAEs). The efficacy endpoints and TEAE analyses were conducted post hoc.

Results

Of the 3923 patients randomized in the 2 INNO2VATE trials, 309 were receiving PD (VADA, N=152; DA, N=157). Among patients receiving PD, MACE rates were similar in the VADA and DA groups (25/152 [16.4%] and 27/157 [17.2%], respectively). The least-squares mean difference in change in Hb from baseline was –0.10 g/dL (95% CI: –0.33, 0.12) to wk 24–36 and –0.19 g/dL (95% CI: –0.43, 0.05) to wk 40–52. Primary and key secondary efficacy endpoints met the prespecified noninferiority margin of –0.75 g/dL. The incidence of overall TEAEs was 88.2% vs 95.5% and of serious TEAEs was 52.6% vs 73.2% in the VADA and DA groups, respectively.

Conclusion

Among patients receiving PD in the INNO2VATE phase 3 trials, safety and efficacy of VADA were comparable to DA.

Funding

  • Commercial Support –