{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T14:00:25Z","timestamp":1792159225716,"version":"4.4.0"},"reference-count":43,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2022,6,14]],"date-time":"2022-06-14T00:00:00Z","timestamp":1655164800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004326","name":"Bayer AG","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,3,31]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Despite available interventions, people with type 2 diabetes (T2D) remain at risk of chronic kidney disease (CKD). Finerenone, a potent and selective nonsteroidal mineralocorticoid receptor antagonist, and sodium\u2013glucose cotransporter 2 inhibitors (SGLT2is) can reduce both kidney and cardiovascular risks in people with CKD and T2D. Here we outline the design of a study to investigate whether dual therapy with finerenone and an SGLT2i is superior to either agent alone.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>CONFIDENCE (NCT05254002) is a randomized, controlled, double-blind, double-dummy, international, multicenter, three-armed, parallel-group, 7.5 - to 8.5-month, Phase 2 study in 807 adults with T2D, stage 2\u20133 CKD and a urine albumin:creatinine ratio (UACR) \u2265300\u2013&amp;lt;5000\u00a0mg\/g. The primary objective is to demonstrate that 6 months of dual therapy comprising finerenone and the SGLT2i empagliflozin is superior for reducing albuminuria versus either agent alone. Interventions will be once-daily finerenone 10\u00a0mg or 20\u00a0mg (target dose) plus empagliflozin 10\u00a0mg, or empagliflozin 10\u00a0mg alone, or finerenone 10\u00a0mg or 20\u00a0mg (target dose) alone.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The primary outcome is a relative change from baseline in UACR among the three groups. Secondary outcomes will further characterize efficacy and safety, including changes in estimated glomerular filtration rate and incident hyperkalemia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>CONFIDENCE is evaluating the safety, tolerability and efficacy of dual use of finerenone and an SGLT2i in adults with CKD and T2D. Should an additive effect be shown, early and efficient intervention with dual finerenone and SGLT2i therapy could slow disease progression and provide long-term benefits for people with CKD and T2D.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ndt\/gfac198","type":"journal-article","created":{"date-parts":[[2022,6,14]],"date-time":"2022-06-14T13:30:31Z","timestamp":1655213431000},"page":"894-903","source":"Crossref","is-referenced-by-count":148,"title":["Design of the COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint study (CONFIDENCE)"],"prefix":"10.1093","volume":"38","author":[{"given":"Jennifer B","family":"Green","sequence":"first","affiliation":[{"name":"Duke University School of Medicine and Duke Clinical Research Institute , Durham, NC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy K","family":"Mottl","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Hypertension, University of North Carolina Kidney Center, UNC School of Medicine , Chapel Hill, NC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George","family":"Bakris","sequence":"additional","affiliation":[{"name":"University of Chicago Medicine , Chicago, IL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiddo J L","family":"Heerspink","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy and Pharmacology, University of Groningen University Medical Centre Groningen , Groningen , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes F E","family":"Mann","sequence":"additional","affiliation":[{"name":"KfH Kidney Centre, Munich, Germany, and Friedrich Alexander University , Erlangen , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet B","family":"McGill","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Metabolism and Lipid Research, Washington University in St. Louis, School of Medicine , St. Louis, MO , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaomi","family":"Nangaku","sequence":"additional","affiliation":[{"name":"University of Tokyo Graduate School of Medicine , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Rossing","sequence":"additional","affiliation":[{"name":"Steno Diabetes Centre Copenhagen , Gentofte , Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen , Copenhagen , Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlie","family":"Scott","sequence":"additional","affiliation":[{"name":"Data Science and Analytics, Bayer PLC , Reading , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Gay","sequence":"additional","affiliation":[{"name":"Medical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG , Berlin , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajiv","family":"Agarwal","sequence":"additional","affiliation":[{"name":"Richard L. 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