{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T23:21:19Z","timestamp":1791328879945,"version":"4.3.1"},"reference-count":29,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2016,7,18]],"date-time":"2016-07-18T00:00:00Z","timestamp":1468800000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Bayer Pharma AG"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2016,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Finerenone (BAY 94\u20138862) is a nonsteroidal mineralocorticoid receptor antagonist in development for the treatment of diabetic kidney disease. This observational trial compared the pharmacokinetics of a single oral dose of finerenone 10\u00a0mg (immediate\u2010release tablet) in adults with mild (creatinine clearance [CL\n                    <jats:sub>CR<\/jats:sub>\n                    ] 50\u201380 mL\/min; n = 8), moderate (CL\n                    <jats:sub>CR<\/jats:sub>\n                    30 to &lt; 50 mL\/min; n = 8), or severe (CL\n                    <jats:sub>CR<\/jats:sub>\n                    &lt; 30 mL\/min; n\u00a0 = \u00a09) renal impairment with those in adults with normal renal function (CL\n                    <jats:sub>CR<\/jats:sub>\n                    &gt; 80 mL\/min; n\u00a0 = 8) over 96 hours postdose. Exposure to finerenone was not affected by mild renal impairment. In participants with moderate or severe renal impairment, exposure to finerenone was increased compared with those with normal renal function (increase in area under the curve for unbound finerenone, 57.1% [outlier excluded] and 46.5%, respectively), with moderate to high interindividual variability. Renal impairment had no consistent effect on the maximum plasma concentration, C\n                    <jats:sub>max<\/jats:sub>\n                    (differences in C\n                    <jats:sub>max<\/jats:sub>\n                    for unbound finerenone of +12% and \u20137% with moderate [outlier excluded] and severe impairment vs normal renal function, respectively). Renal elimination of finerenone is minimal. However, changes in exposure may occur because of the effects of renal impairment on nonrenal routes of elimination.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.263","type":"journal-article","created":{"date-parts":[[2016,3,31]],"date-time":"2016-03-31T05:57:28Z","timestamp":1459403848000},"page":"488-501","source":"Crossref","is-referenced-by-count":66,"title":["Pharmacokinetics of the Novel Nonsteroidal Mineralocorticoid Receptor Antagonist Finerenone (BAY 94\u20138862) in Individuals With Renal Impairment"],"prefix":"10.1002","volume":"5","author":[{"given":"Roland","family":"Heinig","sequence":"first","affiliation":[{"name":"Bayer Pharma AG, Clinical Sciences, Clinical Pharmacology, Cardiovascular and Hematology Pharma Research Centre  Wuppertal Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Kimmeskamp\u2010Kirschbaum","sequence":"additional","affiliation":[{"name":"Bayer Pharma AG, Global Research &amp; Development Statistics Pharma Research Centre  Wuppertal Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atef","family":"Halabi","sequence":"additional","affiliation":[{"name":"CRS Clinical Research Services Kiel GmbH  Kiel Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Lentini","sequence":"additional","affiliation":[{"name":"Bayer Pharma AG, Clinical Sciences, Clinical Pharmacology, Cardiovascular and Hematology Pharma Research Centre  Wuppertal Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,7,18]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.109.895235"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mce.2003.10.005"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.295.22.2638"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehs205"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-7061(03)00913-0"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199909023411001"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009492"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa030207"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2009.1493"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1523-1755.2000.00983.x"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/FJC.0000000000000091"},{"issue":"1","key":"e_1_2_8_13_1","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1001\/jama.1973.03220280028007","article-title":"Adverse reactions to spironolactone","volume":"225","author":"Greenblatt DJ","year":"1973","journal-title":"JAMA"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/cmdc.201200081"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1517\/13543784.2015.1059819"},{"key":"e_1_2_8_16_1","first-page":"7","article-title":"Pronounced cardiac protection by BAY 94\u20108862, a novel non\u2010steroidal mineralocorticoid receptor antagonist in a preclinical rat model of heart failure","volume":"33","author":"Albrecht\u2010K\u00fcpper B","year":"2012","journal-title":"Eur Heart J"},{"key":"e_1_2_8_17_1","first-page":"772","article-title":"Cardiorenal protection by BAY 94\u20108862, a novel non\u2010steroidal mineralocorticoid receptor antagonist in a preclinical model of hypertension and diastolic heart failure","volume":"33","author":"Delbeck M","year":"2012","journal-title":"Eur Heart J"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/eht187"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2015.10081"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/fcp.12170"},{"key":"e_1_2_8_21_1","unstructured":"European Medicines Agency.Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function.2014.http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2014\/2002\/WC500162133.pdf. 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