Kidney International Reports最新文献

{"title":"Exploring Novel Adverse Events of Nefecon","authors":"Jingyu Wang ,&nbsp;Zhao Zhang ,&nbsp;Xingzi Liu ,&nbsp;Sufang Shi ,&nbsp;Jicheng Lv ,&nbsp;Yuemiao Zhang ,&nbsp;Hong Zhang","doi":"10.1016/j.ekir.2024.07.006","DOIUrl":"10.1016/j.ekir.2024.07.006","url":null,"abstract":"<div><h3>Introduction</h3><p>Nefecon, the first innovative drug approved by both the US Food and Drug Administration (FDA) and European Medicines Agency for IgA nephropathy (IgAN), lacked comprehensive real-world assessments of its adverse events (AEs).</p></div><div><h3>Methods</h3><p>We leveraged postmarketing data of Nefecon from the US FDA Adverse Event Reporting System (FAERS), employing disproportionate analysis (DPA) to detect positive signals at the system organ class (SOC) and preferred terms (PTs) levels. Duplicate AEs related to budesonide and those previously reported in studies were excluded through the use of the Medical Dictionary of Regulatory Activities (MedDRA). Our analysis encompassed time-to-onset (TTO), Weibull shape parameter (WSP) evaluation, cumulative incidence, clinical prioritization evaluation, and subgroup analysis based on gender and age.</p></div><div><h3>Results</h3><p>A total of 1515 individuals with IgAN were included. Five positive SOC signals and 23 positive PT signals were identified, including 4 PTs (asthenia, malaise, product dose omission issue, and anxiety) representing novel AEs newly identified in this study. None of the positive PTs were classified as high clinical priority, with only acne, hypertension, swelling face, and weight increased considered as moderate clinical priority events. The median time to TTO was 31 days. All WSP test results indicated an early failure type profile. Lastly, subgroup analysis provided further insights into the relative risk of specific AEs.</p></div><div><h3>Conclusion</h3><p>Nefecon demonstrates a favorable safety profile, with no high-priority clinical events identified. The identification of novel AEs and subgroup-specific relative high-risk events fills a gap in existing studies and offers valuable insights for early clinical vigilance.</p></div>","PeriodicalId":17761,"journal":{"name":"Kidney International Reports","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468024924018229/pdfft?md5=5ac9a3e7a4d438bb3976ce338e3f61aa&pid=1-s2.0-S2468024924018229-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141701368","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Global aHUS Registry Analysis of Patients Switching to Ravulizumab From Eculizumab","authors":"","doi":"10.1016/j.ekir.2024.06.020","DOIUrl":"10.1016/j.ekir.2024.06.020","url":null,"abstract":"<div><h3>Introduction</h3><p>Atypical hemolytic uremic syndrome (aHUS) is a progressive rare disease that, if untreated, can result in severe organ damage and death. Ravulizumab, a next-generation terminal complement inhibitor, provides immediate, complete, and sustained complement C5 inhibition. Real-world data in patients with aHUS who switched to ravulizumab from eculizumab are lacking.</p></div><div><h3>Methods</h3><p>The Global aHUS Registry is a multicenter study (NCT01522183) collecting data on adult or pediatric patients with an aHUS diagnosis, regardless of treatment. Patient characteristics, genetic data, hematological and renal parameters, clinical events (e.g., dialysis and kidney transplantation), and adverse events (AEs) were extracted from patients who switched to ravulizumab from eculizumab up to July 3, 2023.</p></div><div><h3>Results</h3><p>Overall, 60 patients switched to ravulizumab (adult: <em>n</em> = 43; pediatric: <em>n</em> = 17); 11 patients were excluded from effectiveness and genetic analyses (<em>N</em> = 49; adult: <em>n</em> = 40; pediatric: <em>n</em> = 9) because they received &lt;3 months ravulizumab treatment and/or had &gt;1 month between eculizumab discontinuation and ravulizumab initiation. Pathogenic complement variants were identified in 11 of 49 patients (22%); the most common was a complement factor H variant (<em>n</em> = 5/49 [10%]). During ravulizumab treatment, 20 AEs occurred in 13 patients, with no unexpected AEs and only 3 treatment-related AEs (infusion reaction, headaches, and fatigue). No meningococcal infections or deaths were reported. No new events of dialysis, kidney transplantation, or thrombotic microangiopathy were reported. Renal and hematological parameters remained stable after switching to ravulizumab.</p></div><div><h3>Conclusion</h3><p>This is the first real-world cohort analysis of data from patients treated with ravulizumab and reinforces the real-world safety and effectiveness data of ravulizumab in patients with aHUS who switched from eculizumab.</p></div>","PeriodicalId":17761,"journal":{"name":"Kidney International Reports","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468024924017960/pdfft?md5=160bffdab5a77c95ac7fcf4b5f0c2647&pid=1-s2.0-S2468024924017960-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141547466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Combination of Cardiovascular, Kidney, and Metabolic Diseases in a Syndrome Named Cardiovascular-Kidney-Metabolic, With New Risk Prediction Equations","authors":"","doi":"10.1016/j.ekir.2024.05.033","DOIUrl":"10.1016/j.ekir.2024.05.033","url":null,"abstract":"<div><p>Associations of chronic kidney disease (CKD) with metabolic syndrome and cardiovascular disease (CVD) have long been recognized. Until recently, such associations were mainly limited to interrelationships between either heart and kidney, heart and metabolic syndrome, or metabolic syndrome and kidney. It is the merit of the American Heart Association (AHA) to have set up a work group of cardiologists, endocrinologists, and nephrologists for the purpose of combining all 3 disorders in a single entity, as an appreciation of their pathophysiological interrelatedness. To this end, they proposed the term cardiovascular-kidney-metabolic (CKM) syndrome, which reflects multidirectional relationships among metabolic risk factors, CKD, and the cardiovascular system. Following a consensus approach in defining CKM with 5 stages, the work group subsequently developed new risk prediction equations, named predicting risk of CVD events (PREVENT) equations, which included estimated glomerular filtration rate (eGFR) and albuminuria as variables in addition to traditional cardiovascular and metabolic factors. Despite several limitations, this development is a major step forward in cardiovascular risk prediction. Its clinical application should translate into earlier, more appropriate treatment and prevention of CKM syndrome.</p></div>","PeriodicalId":17761,"journal":{"name":"Kidney International Reports","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468024924017571/pdfft?md5=3c6a54741595a08a2910aaa0c6dd3cdc&pid=1-s2.0-S2468024924017571-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141413905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Masked Arginine Vasopressin Deficiency in a Kidney Transplant Recipient With Posttransplant Lymphoproliferative Disorder","authors":"Annie Liu ,&nbsp;Lakshmi Nayak ,&nbsp;Waihay J. Wong ,&nbsp;Inhye E. Ahn ,&nbsp;Naoka Murakami","doi":"10.1016/j.ekir.2024.06.029","DOIUrl":"10.1016/j.ekir.2024.06.029","url":null,"abstract":"","PeriodicalId":17761,"journal":{"name":"Kidney International Reports","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468024924018060/pdfft?md5=12fb9cf9529c003c21de373440d5455b&pid=1-s2.0-S2468024924018060-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141785755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Invisible Threat: How Air Pollution Fuels Primary Glomerular Disease","authors":"Arjunmohan Mohan ,&nbsp;Srinivasan Beddhu","doi":"10.1016/j.ekir.2024.07.023","DOIUrl":"10.1016/j.ekir.2024.07.023","url":null,"abstract":"","PeriodicalId":17761,"journal":{"name":"Kidney International Reports","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468024924018539/pdfft?md5=602bb83f547b126678400de0f450c16c&pid=1-s2.0-S2468024924018539-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141848613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enriched-Culture Polymerase Chain Reaction, a Promising Approach for Diagnosing Tuberculous Peritonitis","authors":"","doi":"10.1016/j.ekir.2024.06.008","DOIUrl":"10.1016/j.ekir.2024.06.008","url":null,"abstract":"","PeriodicalId":17761,"journal":{"name":"Kidney International Reports","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468024924017674/pdfft?md5=c64b076d54515d682e28a870db45d73c&pid=1-s2.0-S2468024924017674-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141411433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pilot Study of a Web-Based Tool for Real-Time Adequacy Assessment of Kidney Biopsies","authors":"","doi":"10.1016/j.ekir.2024.06.019","DOIUrl":"10.1016/j.ekir.2024.06.019","url":null,"abstract":"","PeriodicalId":17761,"journal":{"name":"Kidney International Reports","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468024924017959/pdfft?md5=a6237b32512c42b1ce6abab6f9857124&pid=1-s2.0-S2468024924017959-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141553161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to “WCN24-813 MANAGEMENT OF ACUTE FLUID OVERLOAD IN HEART FAILURE PATIENTS WITH CKD USING HOME DELIVERED SUBCUTANEOUS FUROSEMIDE” [Kidney International Reports Volume 9, Issue 4, Supplement, April 2024, Page S251-S252]","authors":"Rosa Montero ,&nbsp;Ashwin Anenden ,&nbsp;Jane Nokes ,&nbsp;Vasa Gnanapragasam ,&nbsp;Mahrukh Ali ,&nbsp;Sabba Hussain ,&nbsp;Isaac Chung ,&nbsp;Matthew Sunter ,&nbsp;Laura Bijman ,&nbsp;Tristan Williams ,&nbsp;Nicholas Annear ,&nbsp;Irina Chis Ster ,&nbsp;Lisa Anderson ,&nbsp;Debasish Banerjee","doi":"10.1016/j.ekir.2024.07.001","DOIUrl":"10.1016/j.ekir.2024.07.001","url":null,"abstract":"","PeriodicalId":17761,"journal":{"name":"Kidney International Reports","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468024924018175/pdfft?md5=309b9062c8c405979ee8f4c08e2e1668&pid=1-s2.0-S2468024924018175-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141701627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Major Bleeding Rates in an International Cohort of Patients With End-Stage Kidney Disease","authors":"Catelyn R. Coyle ,&nbsp;Lori D. Bash ,&nbsp;Dena Rosen Ramey ,&nbsp;G. Brandon Atkins ,&nbsp;Irina Barash ,&nbsp;Murilo Guedes ,&nbsp;Roberto Pecoits-Filho ,&nbsp;Calvin Andrews ,&nbsp;Angelo Karaboyas ,&nbsp;Marc Bonaca","doi":"10.1016/j.ekir.2024.06.027","DOIUrl":"10.1016/j.ekir.2024.06.027","url":null,"abstract":"","PeriodicalId":17761,"journal":{"name":"Kidney International Reports","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468024924018035/pdfft?md5=247477cf92617954b727e4c1927b9d8b&pid=1-s2.0-S2468024924018035-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141779732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and Rationale of the Phase 2 Baricitinib Study in Apolipoprotein L1–Mediated Kidney Disease (JUSTICE)","authors":"Opeyemi A. Olabisi ,&nbsp;Nadine J. Barrett ,&nbsp;Anika Lucas ,&nbsp;Maurice Smith ,&nbsp;Kenisha Bethea ,&nbsp;Karen Soldano ,&nbsp;Stephanie Croall ,&nbsp;Azita Sadeghpour ,&nbsp;Hrishikesh Chakraborty ,&nbsp;Myles Wolf","doi":"10.1016/j.ekir.2024.06.033","DOIUrl":"10.1016/j.ekir.2024.06.033","url":null,"abstract":"<div><h3>Introduction</h3><p>Individuals of recent West African ancestry develop focal segmental glomerulosclerosis (FSGS) and hypertension-attributed end-stage kidney disease (HTN-ESKD) at 4 times the rate of White Americans. Two protein-coding variants of the Apolipoprotein L1 (APOL1) gene, G1 and G2, explain 50% to 70% of the excess risk of HTN-ESKD and FSGS among this group. Increased expression of G1 and G2 in the kidney, mediated by Janus kinase/signal transducer and activator of transcription (JAK-STAT) signaling, drive pathogenesis of these kidney diseases. Baricitinib is an orally active inhibitor of JAK1/2 that blocks APOL1 synthesis. The Janus kinase-STAT Inhibition to Reduce APOL1-Associated Kidney Disease (JUSTICE) trial is evaluating the antiproteinuric efficacy and safety of baricitinib in patients with APOL1-associated FSGS and HTN-attributed chronic kidney disease (HTN-CKD).</p></div><div><h3>Methods</h3><p>JUSTICE is a single-center, randomized, double-blind, placebo-controlled, pilot phase 2 trial of baricitinib in patients with proteinuria, APOL1-associated FSGS or APOL1-associated HTN-CKD without diabetes. A total of 75 African American patients with APOL1-associated CKD, including 25 with FSGS and 50 with HTN-CKD, aged 18 to 70 years will be randomized 2:1 to daily treatment with baricitinib or placebo, respectively.</p></div><div><h3>Results</h3><p>The primary efficacy end point will be percent change in urine albumin-to-creatinine ratio (UACR) from baseline to end of month 6. The primary safety end point will be incidence of clinically significant decreases in hemoglobin of ≥ 1g/dl.</p></div><div><h3>Conclusion</h3><p>The phase 2 JUSTICE study will characterize the antiproteinuric efficacy and safety of JAK1/2 inhibition with baricitinib in patients with APOL1-associated FSGS and APOL1-associated HTN-CKD.</p></div>","PeriodicalId":17761,"journal":{"name":"Kidney International Reports","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468024924018102/pdfft?md5=d9ae6e7710559c321aa5f5f5996a664a&pid=1-s2.0-S2468024924018102-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141785753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}