|The following article features coverage from Kidney Week 2019. Click here to read more of Renal & Urology News’ conference coverage.|
WASHINGTON—Roxadustat increases hemoglobin levels and decreases the need for intravenous (IV) iron to a greater extent than epoetin alfa in dialysis patients with anemia, according to study data presented at the American Society of Nephrology’s 2019 Kidney Week conference.
In anemic patients with non-dialysis-dependent chronic kidney disease (NDD-CKD), roxadustat increases hemoglobin levels and decreases the risk of requiring rescue therapies such as red blood cell transfusion.
Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and improves iron absorption and utilization.
The findings are from the randomized, phase 3 ROCKIES and OLYMPUS trials. At baseline, the ROCKIES trial included 2106 dialysis patients with anemia (1051 on roxadustat and 1055 on epoetin alfa) and the OLYMPUS trial included 2761 anemic patients with NDD-CKD (1384 on roxadustat and 1377 on placebo). Lead investigator Steven Fishbane, MD, of the Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, presented the findings of both studies during an oral session.
In the ROCKIES trial, the mean hemoglobin change from baseline to an average over weeks 28 to 52 was significantly higher in the roxadustat group compared with epoetin alfa recipients in the overall cohort (+0.77 vs +0.68 g/dL) and among patients with elevated baseline high-sensitivity C-reactive protein (hs-CRP) (+0.80 vs +0.59 g/dL), Dr Fishbane told attendees.
In addition, roxadustat-treated patients required significantly less monthly IV iron than epoetin alfa recipients from week 36 to the end of the study (58.7 vs 91.4 mg). The proportion of patients who required red blood cell transfusions was similar between the study arms.
Common adverse events with roxadustat were generally similar to those of epoetin alfa and commonly found in the dialysis population, Dr Fishbane said.
The study population had a mean age of 54 years, and 59% and 57% of patients were male and white, respectively. Patients had a mean dialysis duration of 37.5 months. Their mean baseline Hb was 10.01 g/dL.
In the double-blind OLYMPUS trial, roxadustat significantly increased hemoglobin levels compared with placebo regardless of iron-repletion status or inflammation, Dr Fishbane said.
The mean change in hemoglobin from baseline to the average over weeks 28 to 52 for the overall study population was +1.75 g/dL among roxadustat-treated patients compared with +0.40 g/dL for placebo recipients. Among patients with elevated hs-CRP, the mean change in hemoglobin level was +1.75 g/dL in the roxadustat-treated patients compared with +0.62 g/dL in the placebo group.
The proportion of patients achieving a hemoglobin response at 2 consecutive visits without anemia rescue therapy was 77% with roxadustat compared with 8.5% with placebo. The investigators defined hemoglobin response as a hemoglobin level of 11 g/dL or higher, a hemoglobin increase greater than 1 g/dL if the hemoglobin level was greater than 8 g/dL at baseline, or a hemoglobin increase of 2 g/dL or higher if the hemoglobin level was 8 g/dL or less at baseline.
In addition, compared with placebo, roxadustat decreased the risk of requiring rescue therapy by 74%, including a 63% decreased risk of red blood cell transfusion, 59% decreased risk of IV iron use, and 87% decreased risk of erythropoietin analog use.
Read more of Renal & Urology News’ coverage of Kidney Week 2019 by visiting the conference page.
Fishbane S, Guzman NJ, Pergola PE, et al. ROCKIES: An international, phase 3, randomized, open-label, active-controlled study of roxadustat for anemia in dialysis-dependent CKD patients. Presented November 7, 2019, at the American Society of Nephrology’s 2019 Kidney Week meeting in Washington, DC. Abstract TH-OR022.
Fishbane S, El-Shahawy MA, Pecoits-Filho R, et al. OLYMPUS: A phase 3, randomized, double-blind, placebo-controlled, international study of roxadustat efficacy in patients with non-dialysis-dependent (NDD) CKD and anemia. Presented on November 7, 2019, at the American Society of Nephrology’s 2019 Kidney Week in Washington, DC. Abstract TH-OR023.