Victoria Socha

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NKF 2021 Spring Clinical MeetingsDaniel Coyne, MD, and colleagues reported pooled results from roxadustat phase 3 studies vis-&agrave;-vis the rates of red blood cell transfusion and volume-related adverse events post-transfusion among non-dialysis-dependent chronic kidney disease (NDD-CKD) patients enrolled in studies of <a href="https://www.docwirenews.com/latest-nephrology-news/blood-transfusion-ckd-anemia/">roxadustat</a> versus placebo.The pooled results were reported during a virtual poster session at the NKF Spring Clinical Meetings 2021. The <a href="https://casehippo.com/spa/symposium/national-kidney-foundation-2021-spring-clinical-meetings/event/gallery/abstracts?abstractId=2082">poster</a> was titled Risk of RBC Transfusion and Volume-Related Adverse Events in Patients with Non-Dialysis-Dependent Chronic Kidney Disease: Pooled Results from Roxadustat Phase 3 Studies.Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. The pooled results were from three double-blind, placebo-controlled, phase 3 studies. Patients in the roxadustat group received roxadustat in doses to maintain hemoglobin (Hb) at 11 gm/dL. To reduce regional variation, the transfusion rate was calculated in US patients, based on Hb &lt;8, 8 to &lt;10, and &ge;10 gm/dL on treatment up to 28 days after last dose. The rates of volume-related adverse events were assessed during the 14 days post-transfusion period and during the follow-up period.The risk of red blood cell transfusion over 52 weeks was reduced by 74% with roxadustat versus placebo in the global NDD-CKD patient pool (hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.21-0.32; P&lt;.0001) and by 81% in the subgroup of US patients (HR, 0.19; 95% CI, 0.12-0.32; P&lt;.0001).In the US patients, the transfusion rate was ~4-fold higher in patients who achieved Hb &lt;10 vs &ge;10 gm/dL, regardless of treatment arm (for roxadustat, 175.2 vs 6.4 events/100 patient exposure years; for epoetin alfa, 174.4 vs 7.2 events/100 patient exposure years).The risk of volume-related adverse events globally was greater in the 14-day post-transfusion period for both arms: roxadustat, 147.1 events/100 patient exposure years versus 13.1 during follow-up; placebo, 121.1 versus 13.4, respectively.In conclusion, the researchers said, &ldquo;Roxadustat reduced the risk of red blood cell transfusion versus placebo in patients with NDD-CKD. In US patients, risk of transfusion was lowest at achieved Hb &ge;10 gm/dL, and globally, volume-related adverse events were higher in the 2-week post-transfusion period.&rdquo;Source: Coyne D, Provenzano R, Szczech L, et al. Risk of RBC transfusion and volume-related adverse events in patients with non-dialysis-dependent chronic kidney disease: Pooled results from roxadustat phase 3 studies. Abstract of a poster presented at the National Kidney Foundation virtual Spring Clinical Meetings 2021 (Abstract #165), April 9, 2021.

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