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Kidney Week

Abstract: PO0451

Efficacy and Safety of Roxadustat in Patients with Anemia of Non-Dialysis-Dependent CKD (NDD-CKD) Treated Continuously for ≥2 Years

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Pecoits-Filho, Roberto, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Dahl, Neera K., Yale University School of Medicine, New Haven, Connecticut, United States
  • Tham, Stefan, Clinical Research, AstraZeneca, Gothenburg, Sweden
  • Orias, Marcelo, Yale University School of Medicine, New Haven, Connecticut, United States
  • Hao, Chuan-Ming, Huashan Hospital Fudan University, Shanghai, China
Background

Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is in development in the US for chronic treatment of anemia of CKD. This pooled post hoc analysis explored outcomes in NDD-CKD patients (pts) treated with roxadustat for ≥2 years (y).

Methods

Pts were randomized to double-blind roxadustat (n=2391) or placebo (PBO; n=1886) for up to 4y in 3 Phase 3 NDD-CKD trials (OLYMPUS, ALPS, ANDES). Oral iron was administered without restriction; intravenous (IV) iron was limited to rescue therapy. Data were analyzed in pts treated for ≥2y, regardless of rescue therapy use. P values are exploratory. Adverse events (AEs) were assessed.

Results

Overall, 789 roxadustat and 392 PBO pts were treated for ≥2y; of these, 87% and 85% completed treatment. Baseline (BL) values for roxadustat vs PBO were not balanced due to more discontinuation in PBO prior to 2y: mean hemoglobin (Hb) 9.2 vs 9.3 g/dL, 59% vs 78% of pts had hypertension, 56% vs 60% of pts had diabetes, mean eGFR 21 vs 24 mL/min/1.73 m2. Change from BL Hb was greater with roxadustat vs PBO over Weeks (wk) 28–52 (+2.0 vs +0.5 g/dL; P<0.001), with differences seen from wk 4, and proportion of pts with Hb ≥10 g/dL over wk 28–52 was higher (95% vs 32%). Roxadustat maintained Hb ~11 g/dL to wk 100 (Figure). Mean roxadustat weekly dose increased by 11% from wk 25–28 to wk 97–100. Rescue therapy need (22% vs 34% pts), including red blood cell (RBC) transfusion (13% vs 18% pts), was less with roxadustat vs PBO; IV iron use was 9% for both. Serious AEs rates with roxadustat vs PBO were 20 vs 17 per 100 pt-exposure years, respectively.

Conclusion

In NDD-CKD pts who remained on treatment for ≥2y, roxadustat maintained Hb ~11 g/dL with minimal dose change and less need for rescue therapy, including RBC transfusion, than PBO.

Funding

  • Commercial Support