BAY 94-8862
Sponsors
Bayer AG, Steno Diabetes Center Copenhagen, Colorado Prevention Center, The George Institute For Global Health, Universitair Medisch Centrum Groningen
Conditions
Chronic kidney diseaseChronic kidney disease associated with type 1 diabetes mellitusDiabetic NephropathiesDiabetic cardiovascular autonomic neuropathyHeart conditionHeart failure due to systemic left ventricular systolic dysfunctionNon-diabetic chronic kidney diseaseProteinuria
Phase 2
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)
CompletedNCT01968668
Start: 2013-10-28End: 2014-11-07Updated: 2021-07-16
The FibroCAN study. Mineralocorticoid receptor antagonist treatment for diabetic cardiovascular autonomic neuropathy
RecruitingCTIS2024-516597-30-00
Start: 2025-05-02Target: 100Updated: 2025-12-16
Phase 3
(22267) A parallel-group, randomized, prospective, interventional, double-blind, multicenter global Phase 3 study to investigate the efficacy and safety of finerenone versus placebo, in addition to standard of care, in participants with chronic kidney disease and type 1 diabetes
CompletedCTIS2022-503024-27-00
Start: 2024-02-27End: 2025-09-15Target: 105Updated: 2025-09-25
(19920) A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weightadjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children, 6 months to <18 years of age, with chronic kidney disease and proteinuria
RecruitingCTIS2023-504884-17-00
Start: 2022-02-04Target: 253Updated: 2025-11-24
(20186 - FIONA OLE) An 18-month, open-label, single-arm safety extension study of an age-and bodyweight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria
RecruitingCTIS2023-504885-50-00
Start: 2022-11-07Target: 69Updated: 2025-11-25
(21177) A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease
Active, not recruitingCTIS2023-506897-11-00
Start: 2021-10-18Target: 391Updated: 2025-10-31
Multifactorial intervention to reduce cardiovascular disease in type 1 diabetes
RecruitingCTIS2023-505794-32-04
Start: 2024-07-05Target: 2000Updated: 2025-11-05
RandomizEd trial to DEtermine the efficacy and safety of FINErenone on morbidity and mortality among heart failure patients with left ventricular ejection fraction greater than or equal to 40% hospitalized due to an episode of acute decompensated Heart Failure (REDEFINE-HF)
RecruitingCTIS2023-508581-15-00
Start: 2024-10-08Target: 1136Updated: 2025-12-15
The Chronic kidney disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect (CAPTIVATE)
WithdrawnCTIS2024-511325-67-00
Target: 300Updated: 2024-11-14
COmbiNed eFfIcacy and safety of an eaRly, intensive MAnagement sTrategy with fInerenOne and SGLT2 iNhibitor in patients hospitalized with Heart Failure (CONFIRMATION-HF)
RecruitingCTIS2023-508874-27-00
Start: 2025-12-02Target: 150Updated: 2025-12-17
A randomized, double-blind, placebo-controlled pragmatic study to evaluate FINerenone on clinicAL effIcacy and safeTY in patients with Heart Failure and reduced ejection fraction who are intolerant of or not eligible for treatment with steroidal mineralocorticoid receptor antagonists (FINALITY-HF)
RecruitingCTIS2023-508875-35-00
Start: 2025-09-01Target: 740Updated: 2026-01-13
(21466) A multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to investigate the efficacy, safety, and PK/ PD of finerenone, in addition to standard-of-care, in pediatric patients, 6 months to < 18 years of age, with heart failure (HF) and left ventricular systolic dysfunction (LVSD)
RecruitingCTIS2024-519829-38-00
Start: 2026-01-09Target: 60Updated: 2026-01-07
(21467) A Phase 3, single-arm, open-label extension study to evaluate the safety of finerenone in addition to standard of care, in pediatric heart failure patients, from birth to 18 years of age, with left ventricular systolic dysfunction (LVSD)
Not yet recruitingCTIS2024-519830-22-00
Target: 61Updated: 2025-12-10
FINE-START; A parallel-group, randomized, prospective, interventional, double-blind, multicenter global Phase 3 study to investigate the efficacy and safety of finerenone versus placebo, in participants with chronic kidney disease not using renin-angiotensin-system inhibitors
Not yet recruitingCTIS2025-523075-32-00
Target: 55Updated: 2025-12-15