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Abstract: PO0261

Risk of Transfusion in Patients with Non-Dialysis-Dependent CKD Increases with Hemoglobin Levels <10 g/dL vs. ≥10 g/dL: Pooled Results from Roxadustat Phase 3 Studies

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Coyne, Daniel W., Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, United States
  • Pecoits-Filho, Roberto, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Rastogi, Anjay, University of California Los Angeles, Los Angeles, California, United States
  • Szczech, Lynda, FibroGen Inc, San Francisco, California, United States
  • Lee, Tyson T., FibroGen Inc, San Francisco, California, United States
  • Pola, Maksym, AstraZeneca, Warsaw, Poland
  • Yu, Kin-Hung Peony, FibroGen Inc, San Francisco, California, United States
Background

Roxadustat is a novel, orally bioavailable, heterocyclic small molecule that reversibly inhibits hypoxia-inducible factor (HIF) prolyl hydroxylase enzymes and activates HIF and transcription of HIF-responsive genes, including erythropoietin. In patients with ESRD, the risk for blood/RBC transfusion is higher in patients with hemoglobin (Hb) levels <10 g/dL vs. those with Hb ≥10 g/dL. We evaluated the efficacy of roxadustat vs. placebo on blood/RBC transfusion by Hb level in US-based patients with non–dialysis-dependent (NDD) CKD.

Methods

Data from three pivotal phase 3, randomized, placebo-controlled studies of roxadustat for the treatment of anemia in NDD patients were assessed. Patients were randomized to receive roxadustat or placebo with periodic dose evaluation/titration. Transfusion was allowed at any time if it was deemed a medical necessity by the Investigator. The incidence rate of transfusion was calculated based on Hb level categorized as: <8.0, 8 to <10, and ≥10 g/dL. Data were evaluated for the on-treatment period + 28 days after the last dose of study drug.

Results

In the overall pooled population of patients with NDD-CKD, roxadustat reduced the risk of transfusion by 74% (HR, 0.26 [95% CI: 0.21, 0.32]; p<0.0001) vs. placebo. When patient-exposure data were stratified by achieved Hb levels, the risk for transfusion increased as Hb levels decreased (Table). The incidence rate of transfusion increased approximately 4-fold in patients with Hb between 8.0 and <10.0 g/dL vs. those with Hb ≥10 g/dL regardless of treatment arm.

Conclusion

In US-based patients with NDD-CKD and anemia treated with roxadustat, the risk of transfusion was approximately 4 times higher in patients with Hb between 8.0 g/dL and <10 g/dL vs. those with Hb ≥10 g/dL.

Table: Incidence rate of transfusion (events/100 PEY) based on Hb level and treatment group
 Roxadustat (n=545)Placebo (n=436)
Hb (g/dL)EventsPEYTransfusion Rate*% of PEY
EventsPEYTransfusion Rate*% of PEY
≥10.050780.76.4084.713181.77.1631.5
8.0 to 10.035133.526.2114.593349.126.6460.5
<8.0148.0175.220.98146.4174.428.0
Total99922.310.73100.0187577.332.39100.0

*Number of events per 100 PEY; Hb, hemoglobin; PEY, patient-exposure years

Funding

  • Commercial Support