Alan Jardine, Steven K. Burke, Wenli Luo, Todd Minga, Mark J. Sarnak, Wolfgang C. Winkelmayer, Rajiv Agarwal, Glenn M. Chertow, Kai-Uwe Eckardt, Mark J. Koury
{"title":"Safety and Efficacy of Vadadustat Versus Darbepoetin Alfa for Chronic Kidney Disease–Related Anemia in Patients Receiving Dialysis by Baseline Erythropoiesis-Stimulating Agent Dose","authors":"Alan Jardine, Steven K. Burke, Wenli Luo, Todd Minga, Mark J. Sarnak, Wolfgang C. Winkelmayer, Rajiv Agarwal, Glenn M. Chertow, Kai-Uwe Eckardt, Mark J. Koury","doi":"10.1111/hdi.70034","DOIUrl":"10.1111/hdi.70034","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Erythropoiesis-stimulating agents (ESAs) and iron supplementation are standard treatments for chronic kidney disease (CKD)–related anemia. Targeting higher hemoglobin values in CKD increases cardiovascular risk. Whether the increased risk is from higher ESA doses or higher hemoglobin levels is uncertain, but alternative therapies are sought for patients requiring high ESA doses. Phase 3 INNO<sub>2</sub>VATE trials in patients with dialysis-dependent CKD (DD-CKD) demonstrated vadadustat's noninferiority compared with darbepoetin alfa. To determine vadadustat's potential to treat anemia, including in patients requiring high ESA doses, its safety and efficacy were compared with those of darbepoetin alfa across prespecified baseline ESA dose subgroups in the prevalent DD-CKD INNO<sub>2</sub>VATE trial.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We compared the safety and efficacy of vadadustat versus darbepoetin alfa across prespecified baseline ESA dose subgroups (low [≤ 90 U/kg/week], intermediate [> 90 and < 300 U/kg/week], or high [≥ 300 U/kg/week]) in the INNO<sub>2</sub>VATE prevalent trial. The primary safety endpoint was time to first adjudicated major adverse cardiovascular event (MACE). Primary and secondary efficacy endpoints were mean hemoglobin level change from baseline at weeks 24–36 and weeks 40–52, respectively.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Findings</h3>\u0000 \u0000 <p>Compared with darbepoetin alfa, first MACE hazard ratios for vadadustat were 0.99 (95% CI, 0.81–1.23), 0.93 (95% CI, 0.74–1.18), and 0.62 (95% CI, 0.34–1.14) for low, intermediate, and high baseline ESA dose subgroups, respectively (interaction <i>p =</i> 0.92). Vadadustat was noninferior to darbepoetin alfa in hemoglobin change from baseline to primary evaluation period, with mean differences (vadadustat–darbepoetin alfa) of −0.10 g/dL (95% CI, −0.19 to −0.02), −0.20 g/dL (95% CI, −0.30 to −0.09), and −0.39 g/dL (95% CI, −0.67 to −0.11) for low, intermediate, and high ESA dose subgroups, respectively.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>Comparing safety and efficacy by baseline ESA dose among patients with CKD on maintenance dialysis, vadadustat was noninferior to darbepoetin alfa for all ESA dose subgroups, including patients with high baseline ESA requirements.</p>\u0000 </section>\u0000 </div>","PeriodicalId":12815,"journal":{"name":"Hemodialysis International","volume":"30 1","pages":"80-100"},"PeriodicalIF":1.2,"publicationDate":"2025-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hdi.70034","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145727865","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Determination of Compassion Fatigue and Brain Fog Levels and Associated Factors Among Hemodialysis Unit Professionals: A Descriptive and Analytical Study","authors":"Serife Cetin, Tugba Aydemir, Setenay Batir","doi":"10.1111/hdi.70039","DOIUrl":"10.1111/hdi.70039","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Hemodialysis professionals are particularly at risk due to the chronic nature of patient care and the intense emotional burden it entails. The aim of this study is to determine the levels of compassion fatigue and brain fog among healthcare professionals working in these units, to examine the relationship between them, and to identify their predictive factors.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This study employed a descriptive and analytical design, with data collected between February 16 and June 16, 2024. Reporting followed the STROBE checklist. The study population consisted of healthcare professionals working in private and public hemodialysis centers in Turkey. A non-probability snowball sampling method was used. Data were collected using a Descriptive Information Form, the Compassion Fatigue–Short Scale, and the Brain Fog Scale.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of the participants, 82.0% were female, and 33.6% were between 36 and 45 years of age. Participants reported moderate levels of compassion fatigue (59.67 ± 21.25) and high levels of brain fog (80.01 ± 26.53). A strong positive correlation was observed between compassion fatigue and brain fog (<i>r</i> = 0.744, <i>p</i> < 0.001). Compassion fatigue levels were significantly predicted by gender, profession, and brain fog (<i>p</i> < 0.005). Conversely, brain fog levels were significantly predicted by the institution of employment, profession, and compassion fatigue (<i>p</i> < 0.005).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>Healthcare professionals experienced moderate levels of compassion fatigue and high levels of brain fog, both of which can impair well-being and job performance. Early recognition and management of these conditions are crucial. Nursing practice and health policy should emphasize supportive interventions such as mental health programs, resilience training, and workload management to protect staff well-being and sustain quality patient care.</p>\u0000 </section>\u0000 </div>","PeriodicalId":12815,"journal":{"name":"Hemodialysis International","volume":"30 1","pages":"158-167"},"PeriodicalIF":1.2,"publicationDate":"2025-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145703602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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