1. Baseline Characteristics of the DISCOVER CKD Prospective Cohort.
- Author
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Pollock C, Carrero JJ, Kanda E, Ofori-Asenso R, Chen H, Garcia Sanchez JJ, Pentakota S, Pecoits-Filho R, Fishbane S, Lam CSP, Kashihara N, and Wheeler DC
- Subjects
- Humans, Female, Male, Middle Aged, Prospective Studies, Aged, Glomerular Filtration Rate, Japan, United States, Sweden, Renal Insufficiency, Chronic, Quality of Life
- Abstract
Introduction: Real-world data from patients with chronic kidney disease (CKD) are limited, particularly regarding clinical management, treatment patterns and health-related quality of life (HRQoL) in the context of new therapies and updated standard of care guidelines., Methods: DISCOVER CKD is an observational cohort study enrolling adult patients with CKD, defined by an International Classification of Diseases, 10th Revision code, or with two estimated glomerular filtration rate measures < 75 ml/min/1.73 m
2 recorded 91-730 days apart. We describe the demographics, baseline characteristics and patient-reported outcomes of patients enrolled in the prospective phase., Results: Of 1052 patients (mean age 62.5 years; 36.9% female) enrolled from the USA, UK, Spain, Italy, Sweden and Japan, 727 (69.1%) had stage 2-3b CKD and 325 (30.9%) had stage 4-5 CKD. Overall, 72.4%, 43.0% and 37.5% of patients had histories of hypertension, diabetes and hyperlipidaemia, respectively. In total, 58.7% and 14.0% were receiving renin-angiotensin-aldosterone system inhibitors (RAASi) and sodium-glucose co-transporter 2 inhibitors (SGLT2i), respectively. Compared with patients with stage 2-3b CKD, patients with stage 4-5 CKD reported numerically greater symptom burden across all 11 symptoms measured, numerically worse HRQoL across all eight categories measured using the 36-item Short Form (SF-36) questionnaire, and numerically greater impairment at work across all four categories measured using the Work Productivity and Activity Impairment chronic kidney disease (WPAI-CKD) questionnaire. Compared with patients with stage 2-3b CKD, a higher proportion of patients with stage 4-5 CKD had anaemia, hyperkalaemia and oedema (49.8% vs. 16.9%, 21.8% vs. 8.4% and 17.5% vs. 9.5%, respectively)., Conclusions: These contemporary real-world data from six countries highlight the substantial symptom, medication and psychosocial burden associated with CKD, and continued gaps in treatment. Graphical abstract available for this article., Trial Registration: ClinicalTrials.gov identifier, NCT04034992., Competing Interests: Declarations. Conflict of Interest: Carol Pollock reports advisory board membership for AstraZeneca, Boehringer Ingelheim, Eli Lilly and Vifor Pharma; and speaker fees for AstraZeneca, Janssen-Cilag, Novartis, Otsuka and Vifor Pharma. Juan-Jesus Carrero reports institutional grants from Astellas, AstraZeneca and Vifor Pharma; speaker fees from AstraZeneca, Abbott and Nutricia; and consultancy for AstraZeneca and Bayer. Eiichiro Kanda is a consultant for AstraZeneca. Richard Ofori-Aseno, Hungta Chen, Juan Jose Garcia Sanchez and Surendra Pentakota are employees of and hold or may hold stock in AstraZeneca. Roberto Pecoits-Filho is an employee of Arbor Research Collaborative for Health, which receives global support for the ongoing Dialysis Outcomes and Practice Patterns Study Programs (provided without restriction on publications by a variety of funders; for details see https://www.dopps.org/AboutUs/Support.aspx ). Roberto Pecoits-Filho also reports: research grants from Fresenius Medical Care; nonfinancial support from Akebia, AstraZeneca, Bayer, Boehringer Ingelheim, Novo Nordisk and FibroGen; personal fees from Travere Therapeutics; and consulting fees from George Clinical outside the submitted work. Steven Fishbane reports research support and consulting fees from AstraZeneca; and research support from Akebia Inc., MegaPro Biomedical Co., Ltd., Ardelyx, Corvidia Therapeutics, Inc. and Cara Therapeutics. Carolyn S. P. Lam is supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from NovoNordisk and Roche Diagnostics; has served as a consultant or is on the advisory board/steering committee/executive committee for Alleviant Medical, Allysta Pharma, Amgen, AnaCardio AB, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, CardioRenal, Cytokinetics, Darma Inc., EchoNous Inc., Eli Lilly, Impulse Dynamics, Intellia Therapeutics, Ionis Pharmaceutical, Inc., Janssen Research & Development LLC, Medscape/WebMD Global LLC, Merck, Novartis, NovoNordisk, Prosciento Inc., Quidel Corporation, Radcliffe Group Ltd., Recardio Inc., ReCor Medical, Roche Diagnostics, Sanofi, Siemens Healthcare Diagnostics and Us2.ai; and serves as co-founder and non-executive director of Us2.ai. Naoki Kashihara is a consultant for AstraZeneca, Boehringer Ingelheim, and Kyowa Hakko Kirin; and receives honoraria from Kyowa Hakko Kirin and Daiichi Sankyo. David C. Wheeler reports personal fees and nonfinancial support from AstraZeneca; and personal fees from Astellas, Bayer, Boehringer Ingelheim, GSK, Janssen, Mundipharma, Napp, Reata Pharmaceuticals, Tricida and Vifor Fresenius. Ethical Approval: This study was performed in accordance with ethical principles consistent with the Declaration of Helsinki, International Conference on Harmonisation, Good Clinical Practice, and the applicable legislation on noninterventional studies and observational studies. The study received central (approval numbers, Italy: 711/19; UK, REC No. 19/YH/0357; Sweden, DNR 2019–05355; Spain 2021/342; and USA, Pro00036594) and local (Japan) institutional review board ethics approval. The names of the central ethics committees that approved the study are Italy: Comitato Etico Indipendente Istituto Clinico Humanitas; Spain: Ethics Committee for Research with Drugs of Galicia; Sweden: Swedish Ethical Review Authority; UK: Health Research Authority; and USA: Advarra. A full list of study sites and their respective ethics committees is provided in Supplementary Table S1. All patients provided written informed consent., (© 2025. The Author(s).)- Published
- 2025
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