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Abstract: PO0460

Comprehensive Safety Profile of Vadadustat from Global Phase 3 Clinical Trials

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Agarwal, Rajiv, Indiana University School of Medicine, Indianapolis, Indiana, United States
  • Vargo, Dennis, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Luo, Wenli, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Solinsky, Christine, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Chertow, Glenn Matthew, Stanford University School of Medicine, Stanford, California, United States
Background

Vadadustat (VADA) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor being investigated for treatment of anemia due to chronic kidney disease (CKD).

Methods

We pooled safety data from 4 global phase 3, randomized, open-label studies evaluating VADA vs darbepoetin alfa (DA) in patients from 2 dialysis- and 2 non–dialysis-dependent CKD trials (INNO2VATE and PRO2TECT, respectively) who received ≥1 dose of study drug. We summarized treatment-emergent adverse events (TEAEs) by MedDRA system organ class (SOC) and preferred term (PT). We retrieved AEs of special interest (AESIs) using Standardized MedDRA Queries and analyzed as groups of PTs (medical topics).

Results

A summary of TEAEs by treatment group is provided (Table). The most common in the VADA and DA groups by SOC were infections and infestations (50.8%, 52.7%), gastrointestinal disorders (40.2%, 35.2%), metabolism and nutrition disorders (34.6%, 36.2%), and injury, poisoning and procedural complications (29.5%, 30.7%). The most common drug-related TEAEs in the VADA group were the PTs of diarrhea (2.2%) and nausea (1.2%), leading to study drug discontinuation in 0.4% and 0.2% of patients, respectively. The most frequent serious AEs (SAEs) in the VADA and DA groups occurred in the SOCs for infections and infestations (23.3%, 24.0%) and renal and urinary disorders (18.6%, 18.1%). TEAEs leading to death in the VADA and DA groups were cardiac arrest (1.7% in each group), end-stage kidney disease (1.8%, 1.3%), and cardio-respiratory arrest (0.9%, 1.0%). AESIs (>10%) in the VADA and DA groups were hypertension (18.0%, 21.0%), congestive heart failure (10.3%, 11.5%), and hyperkalemia (9.9%, 11.9%), all of which were more frequent with DA.

Conclusion

VADA exhibited a TEAE safety profile generally comparable to DA.

Funding

  • Commercial Support