{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T21:54:55Z","timestamp":1793656495808,"version":"4.5.1"},"reference-count":40,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,3,21]],"date-time":"2024-03-21T00:00:00Z","timestamp":1710979200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,3,21]],"date-time":"2024-03-21T00:00:00Z","timestamp":1710979200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004326","name":"Bayer AG","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Innovative Medicines Initiative 2 Joint Undertaking","award":["777389"],"award-info":[{"award-number":["777389"]}]},{"DOI":"10.13039\/501100018936","name":"Universit\u00e4tsklinikum Heidelberg","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100018936","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      Proteinuria is a modifiable risk factor for chronic kidney disease (CKD) progression in children. Finerenone, a selective, non-steroidal, mineralocorticoid receptor antagonist (MRA) has been approved to treat adults with CKD associated with type 2 diabetes mellitus (T2DM) following results from the phase III clinical trials FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049). In a pre-specified pooled analysis of both studies (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200913,026), finerenone was shown to have an acceptable safety profile and was efficacious in decreasing the risk of adverse kidney and cardiovascular outcomes and of proteinuria.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>FIONA and the associated open-label extension (OLE) study aim to demonstrate that combining finerenone with an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) is safe, well-tolerated, and effective in sustainably reducing urinary protein excretion in children with CKD and proteinuria.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>\n                      FIONA (NCT05196035; Eudra-CT: 2021\u2013002071-19) is a randomized (2:1), double-blind, placebo-controlled, multicenter, phase III study of 6\u00a0months\u2019 duration in approximately 219 pediatric patients. Patients must have a clinical diagnosis of CKD (an eGFR\u2009\u2265\u200930\u00a0mL\/min\/1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      if\u2009\u2265\u20091 to\u2009&lt;\u200918 years or a serum creatinine level\u2009\u2264\u20090.40 mg\/dL for infants 6 months to\u2009&lt;\u20091 year) with significant proteinuria despite ACEi or ARB usage. The primary objective is to demonstrate that finerenone, added to an ACEi or ARB, is superior to placebo in reducing urinary protein excretion. FIONA OLE (NCT05457283; Eudra-CT: 2021\u2013002905-89) is a single-arm, open-label study, enrolling participants who have completed FIONA. The primary objective of FIONA OLE is to provide long-term safety data.\n                    <\/jats:p>\n                    <jats:p>FIONA has two primary endpoints: urinary protein-to-creatinine ratio (UPCR) reduction of\u2009\u2265\u200930% from baseline to day 180 and percent change in UPCR from baseline to day 180. A sample size of 198 participants (aged 2 to\u2009&lt;\u200918\u00a0years) in FIONA will provide at least 80% power to reject the null hypothesis of either of the two primary endpoints.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>FIONA is evaluating the use of finerenone in children with CKD and proteinuria. Should safety, tolerability, and efficacy be demonstrated, finerenone could become a useful additional therapeutic agent in managing proteinuria and improving kidney outcomes in children with CKD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov NCT05196035. Registered on 19 January 2022.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-024-08021-z","type":"journal-article","created":{"date-parts":[[2024,3,20]],"date-time":"2024-03-20T23:01:50Z","timestamp":1710975710000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7564-9937","authenticated-orcid":false,"given":"Franz","family":"Schaefer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7350-4475","authenticated-orcid":false,"given":"Giovanni","family":"Montini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hee Gyung","family":"Kang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johan Vande","family":"Walle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua","family":"Zaritsky","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michiel F.","family":"Schreuder","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mieczyslaw","family":"Litwin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Scalise","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Scott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Potts","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pablo","family":"Iveli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefanie","family":"Breitenstein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley A.","family":"Warady","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,3,21]]},"reference":[{"key":"8021_CR1","doi-asserted-by":"publisher","first-page":"1389","DOI":"10.1007\/s00467-022-05816-7","volume":"38","author":"J Harambat","year":"2022","unstructured":"Harambat J, Madden I. What is the true burden of chronic kidney disease in children worldwide? Pediatr Nephrol. 2022;38:1389\u201393.","journal-title":"Pediatr Nephrol"},{"key":"8021_CR2","doi-asserted-by":"publisher","first-page":"583","DOI":"10.1093\/ckj\/sfw047","volume":"9","author":"F Becherucci","year":"2016","unstructured":"Becherucci F, Roperto RM, Materassi M, Romagnani P. Chronic kidney disease in children. Clin Kidney J. 2016;9:583\u201391.","journal-title":"Clin Kidney J"},{"key":"8021_CR3","doi-asserted-by":"publisher","first-page":"1002","DOI":"10.1053\/j.ajkd.2012.07.018","volume":"60","author":"CJ Wong","year":"2012","unstructured":"Wong CJ, Moxey-Mims M, Jerry-Fluker J, Warady BA, Furth SL. CKiD (CKD in children) prospective cohort study: a review of current findings. Am J Kidney Dis. 2012;60:1002\u201311.","journal-title":"Am J Kidney Dis"},{"key":"8021_CR4","doi-asserted-by":"publisher","first-page":"549","DOI":"10.1016\/j.annepidem.2018.05.002","volume":"28","author":"DK Ng","year":"2018","unstructured":"Ng DK, Portale AA, Furth SL, Warady BA, Mu\u00f1oz A. Time-varying coefficient of determination to quantify the explanatory power of biomarkers on longitudinal GFR among children with chronic kidney disease. Ann Epidemiol. 2018;28:549\u201356.","journal-title":"Ann Epidemiol"},{"key":"8021_CR5","unstructured":"United States Renal Data System. 2023 Annual Data Report: Kidney and Urologic Disease among Children and Adolescents. National Institutes of Health, National institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD; 2023. https:\/\/usrds-adr.niddk.nih.gov\/2023\/chronic-kidney-disease\/5-kidney-and-urologic-disease-among-children-and-adolescents. Accessed\u00a026 June 2023."},{"key":"8021_CR6","doi-asserted-by":"publisher","first-page":"631","DOI":"10.1161\/HYPERTENSIONAHA.108.110635","volume":"52","author":"JT Flynn","year":"2008","unstructured":"Flynn JT, Mitsnefes M, Pierce C, Cole SR, Parekh RS, Furth SL, et al. Blood pressure in children with chronic kidney disease: a report from the Chronic Kidney Disease in Children study. Hypertension. 2008;52:631\u20137.","journal-title":"Hypertension"},{"key":"8021_CR7","doi-asserted-by":"publisher","first-page":"2225","DOI":"10.1681\/ASN.2018010036","volume":"29","author":"SM van den Belt","year":"2018","unstructured":"van den Belt SM, Heerspink HJL, Gracchi V, de Zeeuw D, W\u00fchl E, Schaefer F, et al. Early proteinuria lowering by angiotensin-converting enzyme inhibition predicts renal survival in children with CKD. J Am Soc Nephrol. 2018;29:2225\u201333.","journal-title":"J Am Soc Nephrol"},{"key":"8021_CR8","doi-asserted-by":"publisher","first-page":"321","DOI":"10.1007\/s00467-016-3495-1","volume":"32","author":"P Ruggenenti","year":"2017","unstructured":"Ruggenenti P, Cravedi P, Chianca A, Caruso M, Remuzzi G. Achieving remission of proteinuria in childhood CKD. Pediatr Nephrol. 2017;32:321\u201330.","journal-title":"Pediatr Nephrol"},{"key":"8021_CR9","doi-asserted-by":"publisher","first-page":"1639","DOI":"10.1056\/NEJMoa0902066","volume":"361","author":"E W\u00fchl","year":"2009","unstructured":"ESCAPE Trial Group, W\u00fchl E, Trivelli A, Picca S, Litwin M, Peco-Antic A, et al. Strict blood-pressure control and progression of renal failure in children. N Engl J Med. 2009;361:1639\u201350.","journal-title":"N Engl J Med."},{"key":"8021_CR10","doi-asserted-by":"publisher","first-page":"819","DOI":"10.1038\/ki.2012.210","volume":"82","author":"NJ Webb","year":"2012","unstructured":"Webb NJ, Shahinfar S, Wells TG, Massaad R, Gleim GW, Santoro EP, et al. Losartan and enalapril are comparable in reducing proteinuria in children. Kidney Int. 2012;82:819\u201326.","journal-title":"Kidney Int"},{"key":"8021_CR11","doi-asserted-by":"publisher","first-page":"9995","DOI":"10.3390\/ijms22189995","volume":"22","author":"W Baran","year":"2021","unstructured":"Baran W, Krzemi\u0144ska J, Szlagor M, Wronka M, M\u0142ynarska E, Franczyk B, et al. Mineralocorticoid receptor antagonists-use in chronic kidney disease. Int J Mol Sci. 2021;22:9995.","journal-title":"Int J Mol Sci"},{"key":"8021_CR12","doi-asserted-by":"publisher","first-page":"9243","DOI":"10.3390\/ijms23169243","volume":"23","author":"P Kolkhof","year":"2022","unstructured":"Kolkhof P, Lawatscheck R, Filippatos G, Bakris GL. Nonsteroidal mineralocorticoid receptor antagonism by finerenone-translational aspects and clinical perspectives across multiple organ systems. Int J Mol Sci. 2022;23:9243.","journal-title":"Int J Mol Sci"},{"key":"8021_CR13","unstructured":"Bayer HealthCare Pharmaceuticals Inc. KERENDIA (finerenone) tablets, for oral use: US prescribing information. 2021. https:\/\/labeling.bayerhealthcare.com\/html\/products\/pi\/Kerendia_PI.pdf. Accessed June 26 2023."},{"key":"8021_CR14","unstructured":"EMC. Kerendia 10 mg film coated tablets summary of product characteristics. 2022. https:\/\/www.medicines.org.uk\/emc\/product\/13437\/smpc#gref. Accessed 22 June 2022."},{"key":"8021_CR15","unstructured":"Bayer HealthCare Pharmaceuticals Inc. Kerendia summary of product characteristics. 2022. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/kerendia-epar-product-information_en.pdf. Accessed June 26 2023."},{"key":"8021_CR16","doi-asserted-by":"publisher","first-page":"2219","DOI":"10.1056\/NEJMoa2025845","volume":"383","author":"GL Bakris","year":"2020","unstructured":"Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, et al. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med. 2020;383:2219\u201329.","journal-title":"N Engl J Med"},{"key":"8021_CR17","doi-asserted-by":"publisher","first-page":"2252","DOI":"10.1056\/NEJMoa2110956","volume":"385","author":"B Pitt","year":"2021","unstructured":"Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, et al. Cardiovascular events with finerenone in kidney disease and type 2 diabetes. N Engl J Med. 2021;385:2252\u201363.","journal-title":"N Engl J Med"},{"key":"8021_CR18","doi-asserted-by":"publisher","first-page":"474","DOI":"10.1093\/eurheartj\/ehab777","volume":"43","author":"R Agarwal","year":"2022","unstructured":"Agarwal R, Filippatos G, Pitt B, Anker SD, Rossing P, Joseph A, et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J. 2022;43:474\u201384.","journal-title":"Eur Heart J"},{"key":"8021_CR19","unstructured":"Heerspink HJL, Agarwal R, Bakris GL, Cherney D, Lam C, Neuen BL, et al. Effect of finerenone in non-diabetic CKD: design of the FIND-CKD trial in non-diabetic CKD: design of the FIND-CKD trial. Abstract INFO14. Presented at American Society of Nephrology; November 4, 2021."},{"key":"8021_CR20","unstructured":"NAPRTCS. North American Pediatric Renal Trials and Collaborative Studies. 2023. https:\/\/naprtcs.org\/. Accessed Feb 28 2023."},{"key":"8021_CR21","unstructured":"C4C. Connect4Children-proof of viability studies. 2023. https:\/\/conect4children.org\/studies\/. Accessed Feb 28 2023."},{"key":"8021_CR22","unstructured":"ESCAPE NETWORK. The FIONA Study. https:\/\/www.escapenet.eu\/projects\/fiona\/. Accessed 6 November 2023"},{"key":"8021_CR23","unstructured":"I-ACT. Institute for Advanced Clinical Trials. 2023. https:\/\/www.iactc.org\/. Accessed Feb 28 2023."},{"key":"8021_CR24","doi-asserted-by":"publisher","first-page":"948","DOI":"10.1016\/j.kint.2020.10.047","volume":"99","author":"CB Pierce","year":"2021","unstructured":"Pierce CB, Mu\u00f1oz A, Ng DK, Warady BA, Furth SL, Schwartz GJ. Age- and sex-dependent clinical equations to estimate glomerular filtration rates in children and young adults with chronic kidney disease. Kidney Int. 2021;99:948\u201356.","journal-title":"Kidney Int"},{"key":"8021_CR25","doi-asserted-by":"publisher","first-page":"884","DOI":"10.1001\/jama.2015.10081","volume":"314","author":"GL Bakris","year":"2015","unstructured":"Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, et al. Effect of finerenone on albuminuria in patients with diabetic nephropathy: a randomized clinical trial. JAMA. 2015;314:884\u201394.","journal-title":"JAMA"},{"issue":"1","key":"8021_CR26","doi-asserted-by":"publisher","first-page":"74","DOI":"10.1053\/j.ajkd.2014.02.020","volume":"64","author":"LA Inker","year":"2014","unstructured":"Inker LA, Levey AS, Pandya K, Stoycheff N, Okparavero A, Greene T, et al. Early change in proteinuria as a surrogate end point for kidney disease progression: an individual patient meta-analysis. Am J Kidney Dis. 2014;64(1):74\u201385.","journal-title":"Am J Kidney Dis"},{"key":"8021_CR27","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1053\/j.ajkd.2007.06.013","volume":"50","author":"JA Vassalotti","year":"2007","unstructured":"Vassalotti JA, Stevens LA, Levey AS. Testing for chronic kidney disease: a position statement from the National Kidney Foundation. Am J Kidney Dis. 2007;50:169\u201380.","journal-title":"Am J Kidney Dis"},{"issue":"3","key":"8021_CR28","first-page":"1","volume":"2013","author":"Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO","year":"2012","unstructured":"Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO. clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl. 2012;2013(3):1\u2013150.","journal-title":"Kidney Int Suppl"},{"key":"8021_CR29","doi-asserted-by":"publisher","first-page":"783","DOI":"10.1053\/j.ajkd.2017.12.011","volume":"71","author":"SL Furth","year":"2018","unstructured":"Furth SL, Pierce C, Hui WF, White CA, Wong CS, Schaefer F, et al. Estimating time to ESRD in children with CKD. Am J Kidney Dis. 2018;71:783\u201392.","journal-title":"Am J Kidney Dis"},{"key":"8021_CR30","doi-asserted-by":"publisher","first-page":"878","DOI":"10.1053\/j.ajkd.2015.01.008","volume":"65","author":"BA Warady","year":"2015","unstructured":"Warady BA, Abraham AG, Schwartz GJ, Wong CS, Mu\u00f1oz A, Betoko A, et al. Predictors of rapid progression of glomerular and nonglomerular kidney disease in children and adolescents: The Chronic Kidney Disease in Children (CKiD) cohort. Am J Kidney Dis. 2015;65:878\u201388.","journal-title":"Am J Kidney Dis"},{"key":"8021_CR31","doi-asserted-by":"publisher","first-page":"912","DOI":"10.2215\/CJN.11971116","volume":"12","author":"DY Fuhrman","year":"2017","unstructured":"Fuhrman DY, Schneider MF, Dell KM, Blydt-Hansen TD, Mak R, Saland JM, et al. Albuminuria, proteinuria, and renal disease progression in children with CKD. Clin J Am Soc Nephrol. 2017;12:912\u201320.","journal-title":"Clin J Am Soc Nephrol"},{"key":"8021_CR32","doi-asserted-by":"publisher","first-page":"128","DOI":"10.1016\/S2213-8587(18)30314-0","volume":"7","author":"HJL Heerspink","year":"2019","unstructured":"Heerspink HJL, Greene T, Tighiouart H, Gansevoort RT, Coresh J, Simon AL, et al. Change in albuminuria as a surrogate endpoint for progression of kidney disease: a meta-analysis of treatment effects in randomised clinical trials. Lancet Diabetes Endocrinol. 2019;7:128\u201339.","journal-title":"Lancet Diabetes Endocrinol"},{"key":"8021_CR33","doi-asserted-by":"publisher","first-page":"115","DOI":"10.1016\/S2213-8587(18)30313-9","volume":"7","author":"J Coresh","year":"2019","unstructured":"Coresh J, Heerspink HJL, Sang Y, Matsushita K, Arnlov J, Astor BC, et al. Change in albuminuria and subsequent risk of end-stage kidney disease: an individual participant-level consortium meta-analysis of observational studies. Lancet Diabetes Endocrinol. 2019;7:115\u201327.","journal-title":"Lancet Diabetes Endocrinol"},{"key":"8021_CR34","doi-asserted-by":"publisher","first-page":"596","DOI":"10.1093\/ndt\/gfz184","volume":"36","author":"L Oni","year":"2019","unstructured":"Oni L. Paediatric immune-mediated renal disease: an overview. Nephrol Dial Transplant. 2019;36:596\u20138.","journal-title":"Nephrol Dial Transplant"},{"key":"8021_CR35","doi-asserted-by":"publisher","first-page":"1014","DOI":"10.1093\/ndt\/gfaa294","volume":"37","author":"R Agarwal","year":"2022","unstructured":"Agarwal R, Anker SD, Bakris G, Filippatos G, Pitt B, Rossing P, et al. Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone. Nephrol Dial Transplant. 2022;37:1014\u201323.","journal-title":"Nephrol Dial Transplant"},{"key":"8021_CR36","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0239160","volume":"15","author":"SK Huang","year":"2020","unstructured":"Huang SK, Huang CY, Lin CH, Cheng BW, Chiang YT, Lee YC, et al. Acute kidney injury is a common complication in children and adolescents hospitalized for diabetic ketoacidosis. PLoS ONE. 2020;15: e0239160.","journal-title":"PLoS ONE"},{"key":"8021_CR37","doi-asserted-by":"publisher","first-page":"196","DOI":"10.1016\/j.kint.2022.08.040","volume":"103","author":"GL Bakris","year":"2023","unstructured":"Bakris GL, Ruilope LM, Anker SD, Filippatos G, Pitt B, Rossing P, et al. A prespecified exploratory analysis from FIDELITY examined finerenone use and kidney outcomes in patients with chronic kidney disease and type 2 diabetes. Kidney Int. 2023;103:196\u2013206.","journal-title":"Kidney Int"},{"key":"8021_CR38","doi-asserted-by":"publisher","first-page":"84","DOI":"10.1053\/j.ajkd.2019.06.009","volume":"75","author":"AS Levey","year":"2020","unstructured":"Levey AS, Gansevoort RT, Coresh J, Inker LA, Heerspink HL, Grams ME, et al. Change in albuminuria and GFR as end points for clinical trials in early stages of CKD: a scientific workshop sponsored by the national kidney foundation in collaboration with the US Food and Drug Administration and European Medicines Agency. Am J Kidney Dis. 2020;75:84\u2013104.","journal-title":"Am J Kidney Dis"},{"key":"8021_CR39","doi-asserted-by":"publisher","first-page":"1735","DOI":"10.1681\/ASN.2019010007","volume":"30","author":"LA Inker","year":"2019","unstructured":"Inker LA, Heerspink HJL, Tighiouart H, Levey AS, Coresh J, Gansevoort RT, et al. GFR slope as a surrogate end point for kidney disease progression in clinical trials: a meta-analysis of treatment effects of randomized controlled trials. J Am Soc Nephrol. 2019;30:1735\u201345.","journal-title":"J Am Soc Nephrol"},{"key":"8021_CR40","doi-asserted-by":"publisher","first-page":"1756","DOI":"10.1681\/ASN.2019010009","volume":"30","author":"T Greene","year":"2019","unstructured":"Greene T, Ying J, Vonesh EF, Tighiouart H, Levey AS, Coresh J, et al. Performance of GFR slope as a surrogate end point for kidney disease progression in clinical trials: a statistical simulation. J Am Soc Nephrol. 2019;30:1756\u201369.","journal-title":"J Am Soc Nephrol"}],"updated-by":[{"DOI":"10.1186\/s13063-026-09525-6","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2026,2,4]],"date-time":"2026-02-04T00:00:00Z","timestamp":1770163200000}}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08021-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-024-08021-z","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08021-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T06:41:54Z","timestamp":1770273714000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s13063-024-08021-z"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3,21]]},"references-count":40,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["8021"],"URL":"https:\/\/doi.org\/10.1186\/s13063-024-08021-z","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,3,21]]},"assertion":[{"value":"5 December 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 February 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 March 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 February 2026","order":5,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":6,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":7,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1186\/s13063-026-09525-6","URL":"https:\/\/doi.org\/10.1186\/s13063-026-09525-6","order":8,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"These studies will be conducted in accordance with the protocol and with the following:","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors wrote the article with the assistance of a medical writer funded by the sponsor. The sponsor was involved in the study design and the writing of the report.FS discloses consultant fees for Amgen, Bayer, GSK, Otsuka, and Roche, and advisory committee fees for Alnylam and Bayer. GM discloses advisory committee fees for Alynlam, Bayer, and Chiesi Farmaceutici. JVW discloses advisory committee and consultant fees from Bayer. MFS discloses consultant fees from Bayer and Travere Therapeutics. ML has nothing to disclose. JZ discloses speaker honoraria (including speakers\u2019 bureau, symposia, and expert witness) for Alnylam, Horizon, and Natera, and advisory board fees for Bayer and Kaneka. AS, HS, JAP, PI, and SB are Bayer employees. BAW discloses consultant fees from Bayer, Amgen, Roche, and GSK.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"203"}}