Important nephrology trials. 6%) were classified as nephrology.
Important nephrology trials However, these trials did not consider outcomes specifically in relation to clinical Residual renal function and fluid balance. Although it has been widely recognized for more than 2 decades that the best way to determine the most effective and safest treatment of any particular disease is to conduct randomized controlled trials, 1 far fewer robust RCTs have been performed to address the core questions in nephrology than in other fields of medicine. 2. With proper planning, conduct, and reporting, Nature Reviews Nephrology - The usefulness of total kidney volume (TKV) as a biomarker of disease progression in autosomal dominant polycystic kidney disease is disputed. 2010:165:299-309. The abundance of structured clinical data, combined with the mathematical nature of this specialty, makes it an attractive Nephrology Expertise: Armed with a team of dedicated nephrologists, researchers, and healthcare professionals, American Clinical Trials possesses unparalleled expertise in the field. Show more. _____ Most recently, DP-based clinical trials have been completed in nephrology. 6% vs 15. Bhatt, MD, MPH, FACC Senior Associate Editor, Clinical Trials and News, ACC. The Medpace Advantage for Nephrology & Renal Clinical Trials. The United States has moved to deracialize kidney diagnostics. The landscape of clinical trials in nephrology: a systematic review of Clinicaltrials. The great importance of collecting a large quantity of health-related data among human cohorts, For in stance, the literature indicates that nephrology trials were very limited in number . Several successfully completed clinical trials of novel therapies in glomerular disease were reported in 2023. In most studies, patients who opted for a CC were older and had more comorbidities and worse functional status than patients who opted for dialysis. 2013. 2, 79%/92% rating it critically important, second rank on best-worst scale). Methods. Vascular access function was considered the most important outcome (mean score 7. RRF plays an important role in the maintenance of fluid balance in dialysis patients. This paper aims to provide summaries of the top nephrology trials from 2020 to 2023 deemed to be of greatest importance for pharmacists caring for those with CKD, identified by Canadian pharmacists working in nephology or its related specialty areas. Here we identified all randomized controlled trials in five nephrology and five general journals from 2005-2014. 6% of studies overall. Latest From CNTN. 1 Short-term surrogate end points such as serum calcium and serum phosphate are commonly used in trials, 2, 3 whereas patient-reported outcomes, which reflect how a patient feels and functions, 4, 5 are very rarely reported. 2-4 In 2000, Campbell and colleagues performed This editorial initiative of particular relevance, led by Dr. Now, a phase III trial of two pan-genotypic drugs demonstrates excellent viral clearance with minimal adverse events in HCV-infected patients with advanced kidney disease. 4% absolute and 44% relative risk reduction in stage 3 AKI, it is The ISN-ACT (Advancing Clinical Trials) team presents the May-June 2024 round up of randomized trials in nephrology. Despite the increasing importance of graphical illustrations and visual data in clinical trials, there remains an absence of evidence in clinical trial methodological research to guide optimal use. There were no randomized controlled trials, selection bias or confounding. In addition to established treatments, Stanford offers access to experimental treatment options through clinical trials and cutting-edge research initiatives. Karthik Tennankore discuss the benefit of CNTN membership and the importance of patient engagement within his research. Moreover, nephrology as a whole is known to be woefully lagging behind other medical specialties in quality and sheer number of clinical trials [192–194]. The Importance of Clinical Research Organizations and Nephrology. Timing of initiation of renal-replacement therapy in acute kidney injury. Our medical, operations, and regulatory staff understand the complexities of nephrology & renal disease trials from the perspective of the Sponsor, the clinical investigator, the scientific leader, and the reviewer at the regulatory agencies. Multiple factors have contributed to this problem, including the lack of adequate research funding, scarcity of nephrology investigators at each stage of the translational research The limited availability of randomized controlled trials (RCTs) in nephrology undermines causal inferences in meta-analyses. Jump to Content. 4 In this context, the ITT analysis should remain the main analysis as it An important challenge for these technologies is the need for continuous Nature Reviews Nephrology Four other PAK devices (>10 kg) are approaching first-in-human clinical trials: Studies similar to ours have been conducted in other spe- cialties (3,21–24). The nephrology community has been vexed by the dearth of randomized, controlled trials (RCTs) to guide the generation of clinical practice guidelines and wider health care policy (1, 2). gov. The Patient-Reported Outcome and Quality of Life Instruments Database includes approximately 500 PROMs and provides access to most measures and manuals (). The outcomes reported in trials in nephrology are highly variable and often do not reflect those that are directly and most relevant to patients. A total of 74 articles met the inclusion criteria, Conduct of Clinical Trials in Nephrology” in September 2016. 17 Having completed an international Delphi survey 34 to identify critically important outcome domains by all stakeholder groups, a consensus workshop was convened In order to discuss the most significant barriers to conducting trials in patients with kidney disease and to propose potential solutions, KDIGO (Kidney Disease: Improving Global Outcomes) convened an international multidisciplinary Controversies Conference in Paris, France, titled “Challenges in the Conduct of Clinical Trials in Nephrology” in September 2016. 2022. Clinical trials (CTs) play a substantial role in knowledge and innovation, but require important human and material resources. org Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference OPEN Colin Baigent1,2,14, William G. Michael Moritz, Specialty Chief Editor of the Pediatric Nephrology section, is focused on new insights, novel developments, current challenges, latest discoveries, recent advances, and future perspectives in the field of Pediatric Nephrology. Nephrology trials, compared with cardiology trials, were less likely to involve a procedure (8. Diverse Trials Portfolio : Their extensive range of trials delves into various aspects of kidney disease, offering a comprehensive approach to understanding and treating these conditions. Treatment of heart failure and of hypertrophic cardiomyopathy were hot topics. Conference structure. Best practices for the design of clinical trials for behavioral interventions draw upon human-centered design. Landmark Nephrology is an online educational resource that aims to highlight landmark clinical trials which have shaped the way we practice nephrology. The problems with outcome selection and reporting, including the heterogeneity of outcomes and omission of outcomes of importance to patients in trials, have prompted efforts Studies of nephrology trials have reported that most do not address questions, topics and outcomes that patients consider to be important 7, 8, 9, 10. At the Glomerular Disease Center, we are committed to providing personalized and effective treatment plans tailored to each patient’s needs, leveraging the latest advancements in medical research and patient care. George’s University Hospitals National Background Randomised trials support improved decision-making through the data they collect. . The meeting began with plenary talks that aimed to identify the key themes fordiscussion related to trial design outcome trials, it is important to avoid overly optimistic as-sumptions about treatment effect size, even when there are apparently large effects on disease biomarkers. KDIGO executive conclusions www. The Research Topic solicits brief, forward-looking contributions from the Several successfully completed clinical trials of novel therapies in glomerular disease were reported in 2023. Multiple RCTs are registered or in design, Request PDF | On Aug 28, 2017, Angela Ju and others published Considerations and Challenges in Selecting Patient-Reported Outcome Measures for Clinical Trials in Nephrology | Find, read and cite More randomized trials are urgently needed to address important clinical questions in patients with kidney disease. Keywords: observational studies, randomized controlled trials, causal inference Accordingly, CONSORT (Consolidated Standards for reporting trials) guidelines strongly recommend providing the details of both estimates in clinical trials, because when “ITT and PP provide identical conclusions, the confidence level of the investigator for the study results is augmented”. Importance and implications of exosomes in nephrology and urology Lina Mahl 1 · Johanna Ollig 1 · Verena Schweihof er 1 · Lara Wiegand 1 · Phillipp T orkler 2 · Silke Haerteis 1 · Thiha Aung 1,3 Our study does have important limitations. gov, 5035 (7%) trials involved children in the following areas: 1176 (23%) pediatric infectious disease, 664 (13%) pediatric mental health, 346 (7%) pediatric hematology/oncology, and 213 (4. To improve consistency in reporting outcomes of critical importance to patients and health professionals across trials, the global Standardised Outcomes in Nephrology (SONG) initiative was launched in 2015 and has since established core outcome sets for trials in haemodialysis , transplant , peritoneal dialysis , polycystic kidney disease and children and conduct randomized controlled trials,1 far fewer robust RCTs have been performed to address the core questions in nephrology than in other fields of medicine. However, it remains unknown whether contemporary clinical trials within nephrology are of sufficient quality Explore the latest in nephrology, including recent guidelines and advances in the prevention and management of acute kidney injury and CKD. An important goal of the AKTN is membership of a global clinical trials consortium consisting of multiple clinical trial networks that connect in order to (1) identify international research and clinical priorities, (2) provide a larger pool of renal patients available for trials, and (3) avoid duplication of research trials and development of methodologies. It describes the minimum number of individuals in whom changing an event status would render a statistically significant result nonsignificant. In the 1990s, the Outcome Measures in Rheumatology (OMERACT) initiative was formed, and is perhaps the most widely recognized and largest initiative in the field of core Volunteering to participate in clinical trials helps researchers learn more about diseases and finding new ways to treat them. Most of the adaptive trials with kidney outcomes have focused on critically ill populations at risk for AKI, in which a broad range of preventive or therapeutic interventions were tested [ 60 ]. The Standardised Outcomes in Nephrology—Polycystic Kidney Disease (SONG-PKD) project aims to establish a consensus-based set of core outcomes for trials in PKD (with an initial focus on ADPKD but inclusive of all stages) that patients and health professionals identify as critically important. We aimed to generate consensus among patients/caregivers and health professionals on critically important outcomes for trials in CKD prior to kidney failure and the need for kidney replacement therapy, References. Trials are selected not just for impact, but also to Conduct of Clinical Trials in Nephrology” in September 2016. To address this deficiency, the Australasian Kidney Trials Network, a Collaborative Research Group, was formed in 2005. “Hard” endpoints for chronic kidney disease, such as progression to end-stage renal disease, may not be reached for decades. Timing of initiation of renal-replacement therapy in People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care. In a recently published study, we investigated how important patients (n = 30) and healthcare professionals (n = 12), with experience in the clinical areas of breast cancer and nephrology, consider the outcomes (particularly the primary outcome) measured in a random selection of 20 breast cancer and 24 nephrology published randomised controlled Typically, trials with these endpoints can be successful with only a few hundred patients [4, 8–11]. The Research Topic solicits brief, forward-looking contributions from the The number of RCTs in nephrology has been smaller than those performed in cardiology and other specialties , perhaps due to a relatively delayed recognition of the importance of kidney diseases as a major public health problem and the inclination of funding bodies to direct resources toward areas with the highest disease-specific mortality. Future trials should, at least in part, focus on novel preventive strategies. However, recent trials in the nephrology field achieved inconclusive findings as a result of the inappropriate choice Although it has been widely recognized for more than 2 decades that the best way to determine the most effective and safest treatment of any particular disease is to conduct randomized controlled trials, 1 far fewer robust RCTs have been performed to address the core questions in nephrology than in other fields of medicine. RKF in dialysis patients plays important roles in fluid and salt removal, In kidney transplantation, there is increasing recognition of the need to develop core outcomes spurring some efforts to review outcomes used in trials in kidney transplantation. 2-4 In 2000, Campbell and colleagues performed an extensive search and evaluation of the medical literature for 6 core topics in ESRD and identified only 39 clinical trials Clinical trials (CTs) play a substantial role in knowledge and innovation, but require important human and material resources. Each trial is reviewed in context and their risk of bias in seven key areas assessed. In a bold and provocative 2015 paper “A Brave New Through the global Standardized Outcomes in Nephrology–Hemodialysis initiative, cardiovascular disease was identified as a critically important core domain to be reported in all trials in The importance of incorporating factors related to sex and gender in all a 2022 study of landmark randomized controlled trials in nephrology reported significant under-representation of While the study reports a notable 5% absolute and 15% relative risk reduction in stage 1 AKI, along with a 1. In the last edition of Nephtrials we highlighted some of the problems and barriers in evidence generation in many clinical trials as well as the increasing need for reducing complexity and inefficiencies. Keywords: cardiovascular; myocardial infarction; outcomes; sudden cardiac death Randomized controlled trials have several important limitations. A meta-analysis that included nineteen randomized trials and over 1100 patients with CKD reported that aerobic exercise had a small but positive and clinically meaningful effect on cognitive function, regardless of CKD stage . Clin J Am Soc Nephrol 14: 1788, 2019 [] [PMC free article] [] [Google Scholar]; 2. Announcement. This study aimed to identify critically important vascular access outcomes. These also show problems in the conduct and design of trials in other specialties. Whether non-adherence contributes to this lack of nephrology, Wong’s study highlights important questions about designing and testing interventions to improve edu-cation and decision-making for patients with advanced CKD. In many Unfortunately, interventional nephrology trials constitute a very trivial proportion of all nephrology trials in a recent review of ClinicalTrials. 2, 3, 4 In 2000, Campbell and Rethinking Clinical Trials: Patient-Reported Outcomes; FDA statement on PROMs in Product Development; Ciani et al. 7 , 11 This can be due to strict inclusion criteria. Objectives: This study was conducted to determine statistical guidelines on promotion of methodology’s quality in the articles concerning medical sciences, particularly nephrology, to assist authors and reviewers. Nephrology is well positioned to capitalize on the benefits of AI. nephrology (2. ajkd. 7%), with very few diagnostic, screening, or More randomized trials are urgently needed to address important clinical questions in patients with kidney disease. 5%; P<0. nephrology trials from 2020 to 2023 deemed to be of greatest importance for pharmacists caring for those with CKD, iden-tified by Canadian pharmacists working in nephology or its related specialty areas. In kidney transplantation, there is increasing recognition of the need to develop core outcomes spurring some efforts to review outcomes used in trials in kidney transplantation. Method: Outcomes derived from a systematic review, multi-disciplinary expert panel and patient input were included in a The importance of this point can be appreciated analyzing the results of the A Long-Acting somatostatin on DIsease progression in Nephropathy and therefore have an important impact on clinical decision-making. 8 for patients and caregivers/8. International Conference on Nephrology & Urology will be held during October 20-21, 2023. •Nephrology needs more RCTs to improve care •In the last 12(ish) months we saw advances in treating patients with: •Diabetic kidney disease progressing to dialysis •Glomerulonephritis •Complications of dialysis •Exciting next five years! •More trials •Larger trials •Treatments for problems most important to patients To improve consistency in reporting outcomes of critical importance to patients and health professionals across trials, the global Standardised Outcomes in Nephrology (SONG) initiative was launched in 2015 and has since established core outcome sets for trials in haemodialysis , transplant , peritoneal dialysis , polycystic kidney disease and children and Although it has been widely recognized for more than 2 decades that the best way to determine the most effective and safest treatment of any particular disease is to conduct randomized controlled trials, 1 far fewer robust RCTs have been performed to address the core questions in nephrology than in other fields of medicine. Summary of 3 randomized control trials comparing “early” vs “late” initiation of renal replacement therapy (Bouman 2002 , Jiang 2005, Jamale 2013; EHV: Early high-volume hemofiltration; ELV: Early low-volume hemofiltration; LLV: Late low-volume hemofiltration) More randomized trials are urgently needed to address important clinical questions in patients with kidney disease. High degrees of non-adherence in randomized controlled trials (RCTs) can lead to failure to detect a true treatment effect. The past three decades have seen a growing number of PROMs. 7, 11 This can be due to strict inclusion criteria. 6%) were classified as nephrology. 17 Having completed an international Delphi survey 34 to identify critically important outcome domains by all stakeholder groups, a consensus workshop was convened Pediatric Nephrology - Vesico-ureteral reflux We believe the latter and will present convincing evidence supported by large scale prospective randomized controlled trials that VUR is not the ogre it was thought to be and is not important to find following a UTI (with some exceptions). Age and time on the waiting list are the most important recipient factors that influence survival benefit from transplantation. Key message: Herein we discuss the slow progress in nephrology research that has impacted Each core outcome set includes at least one patient-reported outcome, including fatigue (hemodialysis), life participation (kidney transplantation, peritoneal dialysis, early CKD not yet Basic discovery and clinical trials in diabetic kidney disease (DKD) have continued to be reported in 2023 despite the disruption of research activity by COVID-19 in recent years. Sign Up. Backgrounds Diabetic nephropathy (DN) is one of the most important clinical complications of diabetes mellitus (DM) and is the most common cause of end-stage renal disease. 5%). Building on important mechanistic discoveries about disease onset and progression Advancing American Kidney Health (AAKH): Catalyst for Investment in Kidney Diseases Clinical Trials and Precision Medicine: An Opportunity to Advance Upstream Interventions and the Importance of Nephrology. 22,44-46 The Standardized Outcomes in Nephrology (SONG) initiative was recently formed to establish core outcomes across the full spectrum of chronic kidney disease with an initial focus nephrology, Wong’s study highlights important questions about designing and testing interventions to improve edu-cation and decision-making for patients with advanced CKD. W. It has been 20 years since the Cochrane Collaboration started the global effort to synthesize evidence to improve healthcare. Attention Nephrology Fellows: Compete in the 2nd Annual NephMadness Invitational Tournament at the 2025 NKF Spring Clinical Meeting! November 1, 2024. Author links open overlay panel Csaba P. As with all our favourite flozin trials it had to be stopped early for efficacy, with the composite primary outcome of kidney disease progression or cardiovascular death This week, we will discuss the CREDENCE trial, simply the most important nephrology trial in a generation. Thursday, October 24: David C. Landray1,2, Adeera Levin4, Vlado Perkovic5, Marc A. N2 - We recently reported that according to patients and healthcare professionals in breast cancer and nephrology trials, teams conducting the trials got their choice of primary outcome wrong (72% of the time) more often than they got it right (28% of the time). We were interested in knowing how important patients and Background: Quality of articles’ methodology is one of the important factors which is considered by researchers. Despite increasing global concern for envi- ronmental sustainability, ing for nephrology trials to be environmentally friendly, and ne- cessitates a tailored framework for assessing their CF [8]. 97) for kidney Chronic kidney disease is a major public health problem globally. Although these problems are not unique to nephrology trials, we suggest a focus by nephrologists involved in clinical research to examine lessons learned to improve the yield of future trials in nephrology. The magnitude of sodium and water removal due to RRF is an important determinant of survival in dialysis The Standardized Outcomes in Nephrology – Kidney Transplantation (SONG-Tx) was initiated in 2015 and is focused on developing core outcome domains (ie, what to measure) for all trials in kidney transplantation. Little, PhD, Nephrology Dialysis Transplantation, Volume 28, Issue 6, June 2013, Pages 1371–1376, https://doi. This limitation may 8 Division of Nephrology, University of Washington/Providence Health Care, Spokane, WA, USA. A #NephTrials Chat. In other areas of nephrology, measurement and reporting of trial outcomes is inconsistent, and they are likely subject to outcome reporting bias. The findings that the quality of trial reporting Department of Nephrology, CHU Tours, INSERM SPHERE U1246, University of Tours, University of Nantes, Tours, France. Table 1. What is clinical research? Such approaches are especially important in a field like Nephrology where there are myriads of potential interventions based on complex pathophysiologic states, but where properly designed and conducted RCTs for all of these will probably never materialize. 2%) pediatric cardiology []. We were interested in knowing how important patients and Our findings suggest that the choice of graphical illustrations is an important source of ORB in contemporary nephrology clinical trials. Food and Observational Studies Versus Randomized Controlled Trials: Avenues to Causal Inference in Nephrology. Findings The Global Kidney Patient Trials Network (GKPTN) registry has enrolled 4334 Adoption of the approaches outlined in this report has the potential to dramatically improve the quality of clinical trials in nephrology and substantially enhance the evidence base for the safe We conducted the Improving Chronic Disease Management with Pieces (ICD-Pieces) trial to test the hypothesis that an intervention combining information technology with Nephrology studies evaluating hard clinical endpoints or surrogate endpoints are scarce. They are not good for relapsing and remitting conditions per se, unless you have a real understanding of the cyclic nature of the relapses. Mehrotra R: Advancing American Kidney Health: An Introduction. First, the heterogeneities in several pooled analyses including those of post-operative creatinine at POD-2 and POD-3, blood pH, bicarbonates, base excess, We enrolled patients with chronic kidney disease who had an estimated glomerular filtration rate (eGFR) of at least 20 but less than 45 ml per minute per 1. of randomized controlled trials (RCTs) in nephrology in 2001 was 193 and has gradually increased to 601 by 2015. Chronic kidney disease is a major public health problem globally. 2014;63:771–780. _____ ISN Academy: Transplant Kidney Week 2024: Highlights Plenaries. [66] [67] [68] Compared with conventional light microscopy, DP offers several advantages for clinical trials. It was designed to evaluate the quality and quantity of trials in nephrology, rather than to identify the mechanisms for a relatively low number of published trials in nephrology compared with other internal medicine specialties. Pfeffer6, Peter Rossing7,8, An important factor contributing to the relatively slow pace of nephrology trials is that existing clinical endpoints have significant limitations. Rose whose text, Clinical Electrolytes and Acid Base Disorders, regaled a generation of learners by harnessing the power of original research to In a recently published study, we investigated how important patients (n = 30) and healthcare professionals (n = 12), with experience in the clinical areas of breast cancer and nephrology, consider the outcomes (particularly the primary outcome) measured in a random selection of 20 breast cancer and 24 nephrology published randomised controlled trials []. Initiatives such as the Core Outcome Measures in Effectiveness Trials (COMET), Outcome Measures in Rheumatology (OMERACT), and Standardized Outcomes in Nephrology (SONG) have been launched to bring together patients, caregivers, and health professionals to identify critically important outcomes, to ensure that trials consistently report relevant and Randomized controlled trials have several important limitations. increase the scope, scale, and quality of Background Randomised trials support improved decision-making through the data they collect. for Nephrology Trials in Canada Connecting Researchers and Patients to Support Research and Innovation. Intravascular volume expansion is currently the only effective prevention strategy for CI-AKI, but there is a need for standardized volume expansion procedures. This secondary analysis of a randomized clinical trial examines whether chlorthalidone is In a trial involving 135 participants with IgG4-related disease, inebilizumab was associated with significantly lower flare risk and greater likelihood of complete remission than placebo at 1 Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced Results: Of 40,970 trials overall, 1,054 (2. Nephrology Conference provides a platform for Nephrologists, Urologists, Doctors, Kidney Specialists, Scientists Despite aggressive therapy, lupus nephritis (LN) remains an important predictor of morbidity in patients with systemic lupus erythematosus. P. Such approaches are especially important in a field like nephrology where there are myriads of potential interventions based on Introduction. PD patients with glomerular filtration rate (GFR) < 2 ml/min had greater extracellular fluid volume than those with GFR > 2 ml/min []. 1%), device (7. Deepak L. First, the generalizability of their results is often limited due to sampling bias. The use of robust surrogate markers may accelerate early Key Points. To inform patient-centered practice and policy, trials must address research questions of high priority to patients and clinicians, test interventions that align with the needs and preferences of patients and are acceptable to them, and report outcomes of importance. Baigent C, Herrington WG, Coresh J, Landray MJ, Levin A, Perkovic V, Pfeffer MA, Rossing P, Walsh M, Wanner C, Wheeler DC, Winkelmayer WC, McMurray JJV; KDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrology Conference Participants : Challenges in conducting clinical trials in nephrology: Conclusions from a Kidney Disease A host of newer agents including rituximab, abatacept, and monoclonal antibodies blocking costimulatory targets are in current clinical trials for lupus nephritis. Preclinical animal studies are widely used to test candidate drugs for their capacity to modulate disease processes []. The authors acknowledge the editorial support of Barbara Gillespie, MD, Accordingly, CONSORT (Consolidated Standards for reporting trials) guidelines strongly recommend providing the details of both estimates in clinical trials, because when “ITT and PP provide identical conclusions, the confidence level of the investigator for the study results is augmented”. 4% vs 41. WHY IS IT SO IMPORTANT TO PRESERVE RESIDUAL KIDNEY FUNCTION? Residual kidney function (RKF) may confer many benefits to patients with end-stage kidney disease on maintenance dialysis including associations with better patient survival and health-related quality of life []. Our study does have important limitations. 9%) and less likely to report having a data monitoring committee (40. The use of robust surrogate markers may accelerate early phase drug This paper aims to provide summaries of the top nephrology trials from 2020 to 2023 deemed to be of greatest importance for pharmacists caring for those with CKD, identified by Canadian Over the past year, trial data have emerged on therapeutic interventions in IgA nephropathy and lupus nephritis, including the effects of different doses of glucocorticoids and This paper aims to provide summaries of the top nephrology trials from 2020 to 2023 deemed to be of greatest importance for pharmacists caring for those with CKD, More randomized trials are urgently needed to address important clinical questions in patients with kidney disease. We reviewed nephrology RCTs published in 13 nephrology and four general medical jour - nals between 1 July 2010 and 30 June 2011 (see Supplementary Methods and Supplementary Figure S1 online) to explore these domains. Most nephrology trials were for treatment (75. org lupus nephritis have been completed. Purpose: The Canadian Nephrology Trials Network (CNTN) was formed in 2014 to support Canadian researchers in developing, designing, and conducting prospective studies in nephrology. Trials. 5 for health professionals, with 85%/95% rating it critically important, and top ranked on best–worst scale), followed by Our findings suggest that the choice of graphical illustrations is an important source of ORB in contemporary nephrology clinical trials. Secondary outcomes provide additional information to support decision-making. 1159/000313770. Despite increasing global concern for environmental sustainability, few studies have assessed the environmental impact of CTs and the strategies to mitigate their effects [ 2 ]. in knowledge and innovation, but require important human and material resources. The findings that the quality of trial reporting Artificial intelligence (AI) is increasingly used in many medical specialties. Here, the authors propose Nephrology has led an initiative to develop a collabo-rative partnership of global networks of trial-ready co-horts such as the Global Kidney Patient Trials Network and the Rare Diseases Registry in the United Kingdom, among others. However, nephrology has lagged in adopting and incorporating machine learning techniques. The Fragility Index is a tool for testing robustness of randomized controlled trial results for dichotomous outcomes. 46-0. BACKGROUND Well-designed trials are of paramount importance in improving the delivery of care to patients Although further evidence is needed, we believe that raising awareness in the nephrology community about the possibility of a non-pharmacological alternative to oral anticoagulant therapy in patients with advanced CKD and atrial fibrillation for the prevention of thromboembolic risk can be useful and important to help nephrologists manage these Why Regular Nephrology Consultations Are Important One of the primary reasons for regular nephrology consults is to monitor kidney disease progression. Landmark Trials on the use of Rituximab in ANCA Associated Vasculitis. kidney-international. [provides simple overview of the importance of distinguishing surrogate from patient-relevant final outcomes] Our findings provided important conclusions that can be considered by anesthesiology, nephrology, and surgery teams when performing KT. Systemic conditions that affect the kidneys (e The involvement of patients in nephrology clinical trials is limited despite their ability to prioritize research, help with study design, participation, and implementation of results. In a 2005–2010 study of ClinicalTrials. The use of robust surrogate markers may accelerate early-phase drug More randomized trials are urgently needed to address important clinical questions in patients with kidney disease. Clinical trials of novel drugs have not improved LN "Bringing Nephrology Clinical Trials to Patients: The Role of Community Practices" published on Dec 2023 by American Society of Nephrology. 1. If you already have kidney disease or a related condition, it is essential to speak to a professional who will regularly monitor your health. Reproduced from J Am Soc Nephrol with permission. This pro- Since 1997, the Cochrane Renal Group has produced over 100 systematic reviews that have collectively had an important impact on nephrology care, Basel Quantity and Proportion of Randomized Controlled Trials in Nephrology Compared to Other Subspecialties The PubMed Medical Subject Headings Trials) team collects and publishes a list of important nephrology trials from the latest medical literature. 22,44-46 The Standardized Outcomes in Nephrology (SONG) initiative was recently formed to establish core outcomes across the full spectrum of chronic kidney disease with an initial focus Cardiovascular disease (CVD) affects more than two-thirds of patients receiving hemodialysis and is the leading cause of death in this population, yet CVD outcomes are infrequently and inconsistently reported in trials in patients receiving hemodialysis. Selecting PROMS for Clinical Trials in Nephrology. In order to discuss the most significant barriers to conducting trials in patients with kidney disease and to propose potential solutions, KDIGO (Kidney Disease: Improving Global Outcomes) convened an international multidisciplinary Controversies Conference in Paris, France, titled “Challenges in the Conduct of Clinical Trials in Nephrology” Number of randomized controlled trials (RCT) published in nephrology and 12 other specialties of internal medicine from 1966 to 2002. Medication non-adherence is common among renal dialysis patients. Authors Rinaldo The ISN-ACT (Advancing Clinical Trials) team presents this monthly round up of randomized trials in nephrology. As part of the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) initiative, we convened a consensus Cross-over trials can be really good trial options for a stable disease course. 9 Translational Research Institute, AdventHealth, Orlando, FL, USA. 2). Currently, there is no highly effective medicine that can prevent, halt, or reverse the progressive course of DN. Question How can adaptive platform trials be designed for nephrology?. Well-designed trials are of paramount importance in improving the delivery of care to patients with kidney disease. Add to Mendeley. The move addresses major health-equity issues — but it also shines a light on a problematic clinical test. It is important to learn from the setbacks encountered by prior trials as we seek to expand this real-world evidence base and narrow the know-do gap. The nephrology community publishes the fewest randomized con-trolled trials each year of any medical specialty,1 a trend that persists despite moderate improvements in the last 10 years (Fig 1). 4/8. Friday March 10th . The abundance of structured clinical data, combined with the mathematical nature of this specialty, makes it an attractive Cognitive impairment is common in patients with chronic kidney disease (CKD). Burton “Bud” Rose. Although there are risks, clinical trial participation can be very rewarding because you can help learn more about today’s diseases while also helping discover treatments that may help people in the future. 73 m 2 of body-surface area, or who had Improving care for patients with kidney disease will require a concerted effort to increase the scope, quality, and quantity of clinical trials within nephrology, and frequent categorization of funding source as university may underestimate NIH support. 6, 7 Patients with advanced CKD are often systematically excluded from trials of CVD and diabetes interventions, The ISN-ACT (Advancing Clinical Trials) team presents this monthly round up of randomized trials in nephrology. 10. In the table below, we summarize 3 important RCTs from 2002 – 2013. The ISN-ACT (Advancing Clinical Trials) team presents this monthly round up of randomized trials in nephrology. 1053/j. To avoid misinterpretation and any adverse effect on clinical practice, standards are needed, and adherence is critical. Commentary on STARRT-AKI Investigators; Canadian Critical Care Trials Group, the Australian and New Zealand Intensive Care Society Clinical Trials Group, the United Kingdom Critical Care Research Group, the Canadian Nephrology Trials Network, and the Irish Critical Care Trials Group, Bagshaw SM, et al. Listen to CNTN Nephrologist Dr. The carryover effects are an important issue, and you need to think about what timeframe you need for washout. 4 In this context, the ITT analysis should remain the main analysis as it Conclusions: Patients and HPs believe that all cardiovascular outcomes are of critical importance but consistently identify sudden cardiac death, myocardial infarction, stroke and heart failure as the most important outcomes to be measured in all HD trials. Preclinical animal studies are a fundamental part of translational research, which tries to carry over (Latin: “translatio”) new knowledge from basic science to improve human health []. S. Since 1997, the Cochrane Renal Group has produced over 100 systematic reviews that have collectively had an important impact on Background Underrepresentation of racial and ethnic minorities in clinical trials could worsen disparities but reporting and enrollment practices in nephrology randomized clinical trials have not Randomized trials seeking to address implementation gaps must operate in a real-world setting and so must frequently make trade-offs between internal validity and generalizability. An Opportunity to Advance Upstream Interventions and the Importance of Nephrology. Our data on the quantity and quality of trials in nephrology is of major concern and suggests that clinical research in nephrology, and trials in particular, is in crisis. However, the most effective timing for the initiation of such therapy remains uncertain. Despite this, there are fewer high-quality, high-impact clinical trials in nephrology than other internal medicine specialties, which has led to large gaps in evidence. To Important advances have been made in basic and clinical nephrology research over the past decade, with improved pathological insights into various disease processes and the introduction of new Background: Vascular access outcomes reported across haemodialysis (HD) trials are numerous, heterogeneous and not always relevant to patients and clinicians. Alongside clinical outcomes relating to allograft loss, of randomization reporting in clinical trials in nephrology. gov database . O’Hare AM, Tamura MK, Lavallee DC, Vig EK, Taylor JS, Hall YN, Katz R, Curtis JR, Engelberg RA: Assessment of self-reported prognostic expectations of people undergoing dialysis: United States Renal Data Kidney failure is an important outcome for patients, clinicians, researchers, healthcare systems, payers, the numbers of clinical trials in nephrology have lagged behind those in other specialties. This strategy reinforces the lessons learned from Dr. Through a consensus process involving over 1100 recipients, caregivers, and HCPs from 79 countries, the global Standardized Outcomes in Nephrology (SONG)-Tx initiative has established six core outcomes that should be reported in all kidney transplantation trials (Figure 1) (7, 8, 13). 9%), or genetic (including gene transfer, stem cell and recombinant DNA) intervention In nephrology trials, there are important deficits in the quality of subgroup reporting. Initial clinical data showed that Tripterygium glycosides (TGs), a Vascular access function was considered the most important outcome (mean score 7. This editorial initiative of particular relevance, led by Dr. 2 2023 brought us has dogma shredding data on hyponatremia and the importance of different You have to go back to 2014 to find the last Top Stories in Nephrology without a Flozin (95% CI 0. This deep understanding allows us to bring these perspectives to each This paper aims to provide summaries of the top nephrology trials from 2020 to 2023 deemed to be of greatest importance for pharmacists caring for those with CKD, identified by Canadian pharmacists working in nephology or its related specialty areas. Cardio-protective pharmacological interventions have shown no consistent benefit in RCTs involving dialysis patients. 6%) and 2264 as cardiology (5. 05 The analyses presented at the workshop provided important insight into which endpoints can be used in trials of earlier stages of CKD to predict a treatment’s effect on progression to kidney failure,” said Aliza Thompson, MD, MS, Clinical Team Leader in the Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research (CDER), at the U. Latest News. The need to improve patient-centered care has led to a growing recognition among clinicians, researchers, and policymakers that clinical trials must include outcomes important to patients, such as quality of life ([1][1 The ISN-ACT (Advancing Clinical Trials) team presents this monthly round up of randomized trials in nephrology. We Nephrology trials also were more likely than cardiology trials to include a drug intervention (72. 10,11 The presentations on genetics and diagnosis of Alport syndrome demonstrated that our understanding of the value of genetic testing in Alport syndrome has increased greatly over the past 18 months (Fig. BMC Nephrology is an open access journal publishing original peer-reviewed research articles in all aspects of the prevention, diagnosis and management of These are important findings for patients and physicians when deciding on the choice of preferred treatment. Learn more about why diversity in clinical trials is important In nephrology, the number of adaptive trials has increased over the years, although its proportion as compared to nonadaptive trials has decreased . Their subsequent approval as a treatment for chronic kidney disease (CKD) marked a pivotal shift in the landscape of CKD management. Nephrology Dialysis Transplantation, Volume 36, Issue 7, July 2021, assessment and risk assessment based on pre-implantation renal transplant histology are the subject of ongoing clinical trials. Other legitimate and important endpoints to look at in PD are hospitalization and technique failure rates, although these are often influenced by local factors and may be difficult to compare across countries . Materials and Methods: This study is Groups of trials that are underpowered by insufficient participation may be considered collectively using meta-analysis. 3% vs 48. Further to this, Top Clinical Trials. 043. Another relevant resource is the Patient-Reported Outcomes The survey was completed by 873 participants [224 (26%) patients/caregivers and 649 (74%) health professionals] from 58 countries. Randomized Life Participation. org! There were almost 140,000 unique views of the top 10 trials and top 10 trial updates for the year. it seems important for future studies to carefully consider pragmatic approaches that minimise the burden of study participation and maximise study generalisability. Diabetes is a problem of increasing importance in dialysis centers worldwide, with a prevalence exceeding 40% in the largest renal registry, the United States Renal Data System. Dr. A reputable clinical research organization nephrology can do wonders to the modern-day treatment of kidney diseases. Epub 2010 Apr 20. It is important to understand clinical research and nephrology and its impact on dialysis and end-stage renal disease. Kovesdy, Kamyar Kalantar-Zadeh. Medical research projects play an important role in the future of healthcare in the United States. Systematic reviews of observational studies have grown more common The generalizability of the results of future trials of CI-AKI is an important consideration. 8 However, platform trial methodologies are not •Nephrology needs more RCTs to improve care •In the last 12(ish) months we saw advances in treating patients with: •Diabetic kidney disease progressing to dialysis •Glomerulonephritis •Complications of dialysis •Exciting next five years! •More trials •Larger trials •Treatments for problems most important to patients Landmark Nephrology is an online educational resource that aims to highlight landmark clinical trials which have shaped the way we practice nephrology. 10 Innovative trial design elements are now being incorporated in clinical trials, such as the recent basket trial assessing the efficacy and safety of the endothelin receptor antagonist atrasentan in patients with diabetic kidney disease, IgA nephropathy, focal segmental glomerulosclerosis, and Alport syndrome. Introduction. Community-based research programs can play an important role in this endeavor. org. One important piece of data is the primary outcome — so called because it is what the investigators decide is the most important. Nature Reviews Nephrology The trajectory of AKI is an important outcome in intervention trials, because clinical measures or drugs might influence the course of AKI and subsequently influence Pediatric Nephrology - Vesico-ureteral reflux We believe the latter and will present convincing evidence supported by large scale prospective randomized controlled trials that VUR is not the ogre it was thought to be and is not important to find following a UTI (with some exceptions). Rhew, MD, Global Chief Medical Officer, Microsoft, "Accelerating Health Care Innovation in Nephrology with AI" Friday, October 25: Sekar Kathiresan, MD, CEO, Verve Therapeutics, "From Reading the Genome for Risk to Rewriting It for Cardiovascular Health" Saturday, October 26: Melissa H. 9 AM Eastern, 3 PM Central European, 7:30 PM Indian Standard Time. This pro- Acute kidney injury is common in critically ill patients, many of whom receive renal-replacement therapy. The important question of when to commence renal replacement therapy (RRT) Canadian Nephrology Trials Network, Irish Critical Care Trials Group, Bagshaw SM, Wald R, Adhikari NKJ, et al. Am J Kidney Dis. Originally developed for use in type 2 diabetes mellitus (T2DM), sodium–glucose co-transporter-2 (SGLT2) inhibitors demonstrated diverse cardiovascular- and kidney-protective effects in large outcome trials. International perspectives on patient involvement in clinical trials in nephrology Debasish Banerjee1, Racquel Lowe-Jones1, Sandrine Damster2, Nicola Thomas3, Nicole Scholes-Robertson4, Allison Tong4 and Adeera Levin5; and the ISN-ACT Patient-Engagement in Clinical Trials Group6 1Renal and Transplantation Unit, St. SONG-Kids involves five phases: a systematic review to identify outcomes (both domains and measures) that have been reported in randomised controlled trials involving children aged up to 21 years with CKD; focus groups (using nominal group technique) with adolescent patients and caregivers of paediatric patients (all ages) to identify outcomes in knowledge and innovation, but require important human and material resources. 1% vs 27. Building on important mechanistic discoveries about disease onset and progression Background and objectives Atherosclerotic renal artery stenosis may cause hypertension, chronic kidney disease and heart failure, but large randomized control trials to date have shown no major additional benefit of renal revascularization over optimal medical management. Herrington2, Josef Coresh3, Martin J. Hence, “Translational Nephrology” focusses on the unmet medical Once a month, the ISN-ACT (Advancing Clinical Trials) team collects and publishes a list of important nephrology trials from the latest medical literature. 4%) or prevention (15. , J. Surrogate endpoints in trials: a call for better reporting. ) conducted a literature search in August 2023 to identify relevant nephrology studies published These studies provide important information to guide our appreciation of current practice and consi Recent trials in critical care nephrology Contrib Nephrol. 9 It is anticipated that more platform trials will be initiated in nephrology in the near future. Methods Two investigators (J. Learn about how clinical trials work and see if you match. 5 for health professionals, with 85%/95% rating it critically important, and top ranked on best-worst scale), followed by infection (mean 7. doi: 10. However, we acknowledge a few limitations to our study. Nephrology is specialty of medicine concerned with kidney physiology, kidney disease, the treatment of kidney problems and renal replacement therapy. Clinical trials are key to advancing the treatment of chronic kidney disease, and other kidney diseases. As long-term outcomes in lupus nephritis improve, the toxicity of therapy and risk of relapse become increasingly important determinants of the choice of therapeutic agents. 2-4 In 2000, Campbell and colleagues performed Nephrology had a wild year in 2022. The Aspreva Lupus Management Study (ALMS) maintenance and MAINTAIN nephritis trials provide important information regarding the comparative efficacy and safety of MMF and azathioprine International perspectives on patient involvement in clinical trials in nephrology Debasish Banerjee1, Racquel Lowe-Jones1, Sandrine Damster2, Nicola Thomas3, Nicole Scholes-Robertson4, Allison Tong4 and Adeera Levin5; and the ISN-ACT Patient-Engagement in Clinical Trials Group6 1Renal and Transplantation Unit, St. Clinical trials that measure outcomes that are meaningful to patients will ensure that clinical trials must include outcomes important to patients, such as quality of life. Trials are selected not just for impact, The early termination of the trial due to the efficacy of the intervention speaks to the importance of these results which has subsequently received FDA approval. randomized trials to guide everyday treatment decisions despite the introduction of many new inter-ventions during the past 2 decades. Within the various pediatric subspecialties, there are great differences in clinical trials by subspecialty. This occurs when the study sample or the groups resulting from randomization are not representative of the source population they were drawn from. Trials are selected not just for impact, It is important to note that the study didn’t reach the target sample size, resulting in wide confidence We recently reported that according to patients and health care professionals in breast cancer and nephrology trials, teams conducting the trials got their choice of primary outcome wrong (72% of Methods/Design. It was another great year for trial coverage on ACC. Building on important mechanistic discoveries about disease onset and progression This paper aims to provide summaries of the top nephrology trials from 2020 to 2023 deemed to be of greatest importance for pharmacists caring for those with CKD, identified by Canadian pharmacists working in nephology or its related specialty areas. Most of the other subspecialties have also exhibited the Several successfully completed clinical trials of novel therapies in glomerular disease were reported in 2023. Studies similar to ours have been conducted in other spe- cialties (3,21–24). The aim of this position paper is to review the need for and challenges of patient involvement; to assess the present situation of patient involvement; and to describe the role of International Society of Well-designed trials are of paramount importance in improving the delivery of care to patients with kidney disease. ) conducted a literature search in August 2023 to identify relevant nephrology studies published Attempts to standardize outcomes began 50 years ago when the World Health Organization published recommendations for the minimum requirements for data collection in cancer trials []. Clinical trials in nephrology are largely driven by academia and industry with In this review of contemporary trends in nephrology Our findings suggest there is significant room clinical trials, we found that nephrology trials comprised for improvement within nephrology to . Apr 22, 2019 The Standardized Outcomes in Nephrology – Kidney Transplantation (SONG-Tx) was initiated in 2015 and is focused on developing core outcome domains (ie, what to measure) for all trials in kidney transplantation. George’s University Hospitals National Artificial intelligence (AI) is increasingly used in many medical specialties. Another relevant resource is the Patient-Reported Outcomes Outcomes of critical importance to patients and clinicians may not be currently reported in trials, as these have not been explicitly identified. yryaw mllm ksyoty conp sclltub bdpxak iunse fuie pphe uoqs