Abstract: PO0265
Roxadustat Increases Hemoglobin in Anemic Dialysis-Dependent (DD) CKD Patients Independent of Inflammation
Session Information
- Anemia and Iron Management
October 22, 2020 | Location: On-Demand
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- El-Shahawy, Mohamed A., Keck-USC School of Medicine, Los Angeles, California, United States
- Roger, Simon D., Renal Research, Gosford, New South Wales, Australia
- Manllo-Karim, Roberto, Gamma Medical Research, McAllen, Texas, United States
- Pola, Maksym, Clinical Research, AstraZeneca, Warsaw, Poland
- Tham, Stefan, Clinical Research, AstraZeneca, Gothenburg, Sweden
- Szczech, Lynda, FibroGen Inc., San Francisco, California, United States
- Pollock, Carol A., The University of Sydney, Sydney, New South Wales, Australia
Background
Inflammation is a common cause of decreased responsiveness to erythropoiesis-stimulating agents. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, treats anemia by inducing endogenous erythropoietin production and increasing iron utilization via reducing hepcidin. Roxadustat efficacy has been shown in those with inflammation, as defined by baseline (BL) elevation of high sensitivity C-reactive protein (hsCRP). This pooled analysis explored the efficacy of roxadustat in correcting Hb in DD-CKD patients across the spectrum of baseline hsCRP values.
Methods
Data from three randomized Phase 3 pivotal trials in anemic patients with DD-CKD were pooled and the efficacy of roxadustat in increasing hemoglobin (Hb) from BL was assessed. hsCRP concentration was used as a marker of inflammation; patients with hsCRP >5 mg/L were considered to have inflammation at BL. Mean Hb change from BL (CFB) to Weeks 28–52 was summarized by BL hsCRP quintile. Roxadustat dose requirements at Week 24 were based on mean weekly dose in mg per kg of mean BL weight.
Results
Overall, 1538 roxadustat-treated DD-CKD patients were assessed and had a mean BL hsCRP of 10.5 mg/L. Mean BL Hb measures were similar across the hsCRP quintiles (range 9.5–9.7 g/dL). In patients with BL inflammation (n=723), mean Hb CFB to Weeks 28–52 was 1.29 g/dL with roxadustat. Mean Hb CFB to Weeks 28–52 was similar across all hsCRP quintiles in roxadustat-treated patients (Figure). Mean weekly roxadustat doses at Week 24 for BL hsCRP quintiles 1 through to 5 were comparable at 3.9, 3.4, 3.5, 3.3, and 3.6 mg/kg, respectively.
Conclusion
Roxadustat increased Hb in anemic DD-CKD patients independent of inflammation.
Funding
- Commercial Support –