Roxadustat Treatment Corrects Anemia to Hemoglobin (Hb) Values ≥10 g/dL in the Majority of Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)

Background: The Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guidelines recommend the treatment of anemia in NDD-CKD patients with Hb <10 g/dL to reduce associated symptoms and prevent the need for red blood cell transfusions. Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor studied for the treatment of anemia in patients with CKD through increasing erythropoietin synthesis and enhancing iron utilization. We studied the percentage of patients with NDD-CKD treated with roxadustat achieving Hb ≥10 g/dL.

Methods: Patients with Hb <10 g/dL and estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² were randomized to roxadustat or placebo in 3 pivotal double-blind NDD-CKD trials (OLYMPUS, ANDES and ALPS). The cumulative percentage of patients with Hb ≥10 g/dL for at least 2 consecutive visits was analyzed monthly over 12 months of roxadustat treatment, using the number of patients remaining on roxadustat treatment at each time point as the denominator. Hb values were censored for 6 weeks following rescue therapy.

Results: In total, 2391 patients received roxadustat. Mean Hb at baseline was 9.1 g/dL and mean eGFR was 19.7 mL/min/1.73 m². Among patients still on roxadustat treatment, the cumulative percentage of patients with Hb ≥10 g/dL for at least two consecutive visits was 38.3%, 75.5%, and 87.0% at months 1, 2, and 3, respectively, and 96.4% at month 6 (Figure). Among patients still receiving roxadustat treatment at 12 months, the cumulative percentage with confirmed Hb ≥10 g/dL was 99.0%.

Conclusion: Roxadustat effectively raised Hb levels in NDD-CKD patients, with over 95% of patients achieving Hb ≥10 g/dL after 5 months of treatment.