Roxadustat Versus Epoetin Alfa for Treating Anemia in Patients with Chronic Kidney Disease on Dialysis: Results from the Randomized Phase 3 ROCKIES Study

Fishbane, Steven; Pollock, Carol; El-Shahawy, Mohamed; Escudero, Elizabeth T; Rastogi, Anjay; Van, Bui Pham; Frison, Lars; Houser, Mark T.; Pola, Maksym; Little, Dustin J.; Guzmán, Nicolás; Pèrgola, Pablo E.

doi:10.1681/asn.2020111638

Cited by 79 publications

(163 citation statements)

References 28 publications

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“…Taken orally, Roxadustat is associated with more gastrointestinal side effects. Studies from Europe and Asia reported similar points in terms of serious adverse events [ 19 , 21 , 24 ]. In our study, patients on Roxadustat experienced more vomiting and nausea when compared to those on EPO.…”

Section: Discussionmentioning

confidence: 73%

“…The significant presence of patients on peritoneal dialysis in the Roxadustat group could have affected the mean potassium level of the overall group and consequently explain why we do not find hyperkalemia as an adverse event. Also, hyperkalemia as an adverse effect of Roxadustat has been reported much more in studies that had a placebo as a comparator and in non-dialysis patients [ 21 ]. Patients without any replacement therapy (HD or PD) may experience metabolic acidosis or hyperkaliemia over time.…”

Section: Discussionmentioning

confidence: 99%

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Safety and Effectiveness of Roxadustat in Dialysis-Dependent Patients With Renal Anemia: A Hospital-Based Cohort Study

Moussa¹,

Feng²,

Wang³

et al. 2022

Cureus

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Background Randomized controlled trials (RCTs) have shown the efficacy and safety of Roxadustat and conclude that it has the potential to change the treatment for anemia associated with chronic kidney disease. However, the experience of its use from clinical perspectives post-approval is lacking. Aim Using a clinical practice context, this study aims to compare Roxadustat's effectiveness and tolerability with Erythropoietin (EPO) in patients with renal anemia undergoing dialysis. Methods We examined the clinical records of patients with a diagnosis of renal anemia on dialysis who were prescribed Roxadustat or Erythropoietin at the department of nephrology of the First Affiliated Hospital of Gannan Medical University from January 2021 to December 2021. Eligible hemodialysis (HD) or peritoneal dialysis (PD) patients with renal anemia, aged >18 or <75 years, without infection, active bleeding, and malignancy were recruited. These patients received Roxadustat or EPO based on the preferential prescription choice made by the nephrologists of the department. We retrospectively attempted to determine the treatment response measured by the change in hemoglobin rate, from baseline up to six months. We also explored the impact of various factors on the treatment response and reported adverse events. Results A total of 106 patients have been included in the final analysis, with 53 patients in each group. The mean age of the study group was 49.9 ± 13.6 years with the main Hb level at the baseline of 8.1 g/dL ± 1.23 g/dl. The gain of hemoglobin from the baseline averaged over six months was 2.2 ± 2.11 g/dl in the Roxadustat group compared with 1.1 ± 1.67 g/dL in the EPO group ( p=0.01 ) . As compared to EPO,Roxadustat reduced the total cholesterol level by -0.59 ± 1.08 mmol/l versus -0.01 ± 1.28 mmol/l ( p=0012 ) and the low-density lipoprotein (LDL) cholesterol by -0.48 ± 1.07 mmol/l versus -0.47 ± 1.05 ( p=0.017 ) in the first three months. Associated factors with a non-response to treatment were age greater than 65 years (OR=6, 95% CI: 1.23-32.46, p=0.02 ), hypertension (OR=3.5, 95%CI: 0.89-13.25, p=0.060 ), and heart failure (OR=4.18, 95%CI:4.18 1.04-20.39, p=0.040 ). Although the proportion of hospitalization and infection was higher in the EPO group and the incidences of gastrointestinal symptoms (vomiting, nausea) and blood transfusions were higher in the Roxadustat group, there were no statistically significant differences. Conclusion Roxadustat improved hemoglobin compared to erythropoietin in patients undergoing dialysis with a safe profile but precautions should be taken for old patients with a cardiovascular medical history.

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Section: Discussionmentioning

confidence: 73%

Section: Discussionmentioning

confidence: 99%

Safety and Effectiveness of Roxadustat in Dialysis-Dependent Patients With Renal Anemia: A Hospital-Based Cohort Study

Moussa¹,

Feng²,

Wang³

et al. 2022

Cureus

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“…Therefore, there is a need to identify alternative therapeutic approaches. Systemic administration of EPO is used to treat adult anemia and has been discussed as a potential treatment for atrophic AMD due to its neuroprotective effects on the retina [ 7 , 37 ]; however, there are associations between increased serum EPO and severity of CNV in AMD patients [ 9 ]. Furthermore, EPO-induced neural protection and angiogenesis have been demonstrated in experimental models through EPOR-mediated signaling [ 10 , 21 ].…”

Section: Discussionmentioning

confidence: 99%

Role of Erythropoietin Receptor Signaling in Macrophages or Choroidal Endothelial Cells in Choroidal Neovascularization

et al. 2022

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Erythropoietin (EPO) has been proposed to reduce the progression of atrophic age-related macular degeneration (AMD) due to its potential role in neuroprotection. However, overactive EPO receptor (EPOR) signaling increased laser-induced choroidal neovascularization (CNV) and choroidal macrophage number in non-lasered mice, which raised the question of whether EPOR signaling increased CNV through the recruitment of macrophages to the choroid that released pro-angiogenic factors or through direct angiogenic effects on endothelial cells. In this study, we addressed the hypothesis that EPOR signaling increased CNV by direct effects on macrophages or endothelial cells. We used tamoxifen-inducible macrophage-specific or endothelial cell-specific EPOR knockout mice in the laser-induced CNV model, and cultured choroidal endothelial cells isolated from adult human donors. We found that macrophage-specific knockout of EPOR influenced laser-induced CNV in females only, whereas endothelial-specific knockout of EPOR reduced laser-induced CNV in male mice only. In cultured human choroidal endothelial cells, knockdown of EPOR reduced EPO-induced signal transducer and activator of transcription 3 (STAT3) activation. Taken together, our findings suggest that EPOR signaling in macrophages or choroidal endothelial cells regulates the development of CNV in a sex-dependent manner. Further studies regarding the role of EPO-induced signaling are required to assess EPO safety and to select or develop appropriate therapeutic approaches.

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“…As a hypoxia-inducible factor prolyl hydroxylase inhibitor, the novel agent roxadustat may increase endogenous erythropoietin concentrations by mediating the hypoxia-inducible factor, which is regulated via the inhibition of certain activated domains, such as pan-prolyl hydroxylase (9). Subsequently, it has been incorporated into the therapeutic regimen for anemia in CKD (10).…”

Section: Introductionmentioning

confidence: 99%

Comparison of efficacy of roxadustat and erythropoietin for the treatment of renal anemia in patients with chronic kidney disease: a retrospective study

Jin¹,

Zhang²,

Luo³

et al. 2022

Transl Androl Urol

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Background: Renal anemia is a common complication in patients with end-stage renal disease (ESRD).Both roxadustat and recombinant human erythropoietin (rhEPO) are alternative option for patients with renal anemia. However, the adverse events of rhEPO limited the wide use of it and the concrete difference of real clinical efficacy of rhEPO and roxadustat was still uncertain. This study aimed to assess the clinical efficacy of roxadustat for improving renal anemia in patients with chronic kidney disease.Methods: A retrospective cohort study of 790 consecutive patients with renal anemia treated with roxadustat and rhEPO was conducted at the Zhejiang Provincial People's Hospital. Patients were classified into two groups: roxadustat (n=95) and rhEPO (n=695). Baseline characteristics were compared in two groups. After propensity-score matching at a 1:3 ratio, we compared the efficacy of roxadustat and rhEPO in improving anemia, mainly using the Mann-Whitney U test. The follow-up period lasted 24 weeks. Results:The baseline characteristics were comparable between the two groups after propensity-score matching. There were no significant differences in the hemoglobin levels and estimated glomerular filtration rates (eGFRs) of the two groups before roxadustat or rhEPO treatment (P>0.05). The hemoglobin level after 4 weeks of treatment was 96 g/L in the roxadustat group, and the increase from baseline was 10 g/L; in the rhEPO group, these values were 87 and 6 g/L, respectively (P<0.001). After 12 weeks of treatment, the hemoglobin level and change from baseline were 105 and 15 g/L in the roxadustat group and 94 and 11 g/L in the rhEPO group, respectively (P<0.001). Similar results were observed after 24 weeks of treatment; the hemoglobin level and change from baseline were 105 and 17 g/L in the roxadustat group and 97 and 14 g/L in the rhEPO group (P=0.001).Conclusions: This retrospective study demonstrated that orally administered roxadustat improved hemoglobin levels more than rhEPO in patients with CKD and anemia.

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Roxadustat Versus Epoetin Alfa for Treating Anemia in Patients with Chronic Kidney Disease on Dialysis: Results from the Randomized Phase 3 ROCKIES Study

Cited by 79 publications

References 28 publications

Safety and Effectiveness of Roxadustat in Dialysis-Dependent Patients With Renal Anemia: A Hospital-Based Cohort Study

Safety and Effectiveness of Roxadustat in Dialysis-Dependent Patients With Renal Anemia: A Hospital-Based Cohort Study

Role of Erythropoietin Receptor Signaling in Macrophages or Choroidal Endothelial Cells in Choroidal Neovascularization

Comparison of efficacy of roxadustat and erythropoietin for the treatment of renal anemia in patients with chronic kidney disease: a retrospective study

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