{"id":1402,"date":"2024-05-10T15:16:03","date_gmt":"2024-05-10T13:16:03","guid":{"rendered":"https:\/\/www.incipit-pediatric.net\/trials\/fiona-e-fiona-ole\/"},"modified":"2026-10-19T11:32:41","modified_gmt":"2026-10-19T09:32:41","slug":"fiona-e-fiona-ole","status":"publish","type":"trials","link":"https:\/\/www.incipit-pediatric.net\/en\/trials\/fiona-e-fiona-ole\/","title":{"rendered":"FIONA e FIONA OLE"},"content":{"rendered":"<p class=\"x_MsoNormal\"><strong><i>FInerenone for the treatment of children with chrOnic kidNey disease and proteinuriA<\/i><\/strong><\/p>\n<p class=\"x_MsoNormal\">A 6-month, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and PK\/PD of an age- and bodyweight-adjusted oral finerenone regimen, as an adjunct to an ACEI or ARB, for the treatment of children aged 6 months &lt;to &lt;18 years.<\/p>\n<p class=\"x_MsoNormal\">ACEI or ARB, for the treatment of children aged 6 months to &lt;18 years with chronic kidney disease and proteinuria.&lt;<\/p>\n<p class=\"x_MsoNormal\">Finerenone has been shown to be safe and effective in reducing proteinuria and decreasing the risk of renal events, such as renal failure, and cardiovascular events in high-risk populations with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2D).<\/p>\n<p class=\"x_MsoNormal\">The objective of the study is to demonstrate that Finerenone, in addition to an ACEI or an ARB, is safe and effective in reducing urinary protein excretion which represents a modifiable risk factor for worsening renal function in children with CKD and severely increased proteinuria.<\/p>\n<p class=\"x_MsoNormal\">The extension study, FIONA OLE, will be an 18-month, single-arm, open-label, multicenter study to evaluate the long-term safety and efficacy of an age- and body weight-adjusted oral finerenone regimen, as an adjunct to an ACEI or an ARB, for the treatment of pediatric and young adult patients, aged 1 &lt;to &lt;19 years, with CKD stages 1-3. Only patients who have completed the double-blind FIONA study will be eligible for inclusion in the FIONA OLE study.<\/p>\n<p class=\"x_MsoNormal\">The main aim of the study is to provide data on the long-term safety of Finerenone in the treatment of pediatric and young adult patients with CKD.<\/p>\n<div><strong>Status: Completed<\/strong>.<\/div>\n","protected":false},"excerpt":{"rendered":"<p>FInerenone for the treatment of children with chrOnic kidNey disease and proteinuriA A 6-month, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and PK\/PD of an age- and bodyweight-adjusted oral finerenone regimen, as an adjunct to an ACEI or ARB, for the treatment of children aged 6 months &lt;to &lt;18 years. ACEI or [&hellip;]<\/p>\n","protected":false},"featured_media":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-1402","trials","type-trials","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.incipit-pediatric.net\/en\/wp-json\/wp\/v2\/trials\/1402","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.incipit-pediatric.net\/en\/wp-json\/wp\/v2\/trials"}],"about":[{"href":"https:\/\/www.incipit-pediatric.net\/en\/wp-json\/wp\/v2\/types\/trials"}],"wp:attachment":[{"href":"https:\/\/www.incipit-pediatric.net\/en\/wp-json\/wp\/v2\/media?parent=1402"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}